Estados Unidos Recalls

Prince Bakery Inc Issues Allergy Alert on Undeclared Milk and Sesame in Prince Bakery Breads

MARKON LETTUCE SALAD MIX 4/5# MARKON LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

Cross Valley Farms BLEND LETT/ROM 50/50 NOCLR 4/5# Cross Valley Farms BLEND LETT/ROM 80/20 4/5# Iceberg, Romaine products.

Potential Cyclospora contamination.

YUM LETTUCE SHREDDED 1/4" 6/5# Iceberg only products.

Potential Cyclospora contamination.

SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit. Component: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.

Due to off-the-shelf display port component that has audio/video failures

Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE R , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

MARKON LETTUCE CHOP 4/5# MARKON LETTUCE SHRED 1/4" 4/5# MARKON LETTUCE SHRED 1/8" 4/5# MARKON LETTUCE SHRED 3/8" 4/5# Iceberg only products.

Potential Cyclospora contamination.

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

Cross Valley Farms LETTUCE SALAD MIX 4/5# Cross Valley Farms LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Lack of assurance of sterility. The recall is due to potential contamination

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.

Products may not have received adequate sterilization processing.

TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# NATIONAL TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# ND TAYLOR FARMS BLEND LETT/ROM 50/50 NOCLR 4/5# TAYLOR FARMS BLEND LETT/ROM 70/30 NOCOLR 4/5# TAYLOR FARMS BLEND LETT/ROM 80/20 4/5# TAYLOR FARMS LETTUCE SALAD MIX 4/5# Iceberg, Romaine products.

Potential Cyclospora contamination.

SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Kroger, Medium, 30 Eggs, Net Wt 52.5 oz (3lb 4.5oz) 596g, UPC 0 11110-60980 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Kroger, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-60903 8. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Kroger, Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 11110-60933 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 5. Kroger, Large 60 Eggs, Net Wt 7lb 8oz (3.40kg), UPC 0 11110-60933 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 6. Kroger, Extra Large 12 Eggs, Net Wt 27 oz (1lb 11oz) 766g, UPC 0 11110-60904 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 7. Kroger, Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 11110-60905 2. Distributed by The Kroger Co., Cincinnati, OH 45202. Packed by Tx Lic #613171, 800 Wabash Rd, N. Manchester, IN 46962. 8. Brookshire's farm fresh, Large 6 Eggs, Net Wt 12 oz (341g), UPC 0 92825-09564 4. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 9. Brookshire's farm fresh, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 92825-09555 2. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 10. Brookshire's farm fresh, Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 92825-09556 9. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 11. Brookshire's farm fresh, Large 36 Total Eggs TWIN PACK (18 Each), Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 92825-10980 8. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 12. Super 1 Foods Large 60 Eggs, Net Wt 120 oz (7lbs8oz) 3.4kg, UPC 0 92825-09563 7. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 13. Brookshire's farm fresh, Extra Large 18 Eggs, Net Wt 40.5 oz (2lb 8.5oz) 1.15kg, UPC 0 92825-09560 6. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 14. Brookshire's farm fresh, Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 92825-09558 3. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. Packed by MPS Egg Farms, 14374 E State Hwy 21, Byran, TX 77808. 15. Country Morning Medium 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 78566-00104 5. 16. Country Morning Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 78566-20000 4. 17. Country Morning Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 78566-00503 6. 18. Country Morning Large 2 1/2 Dozen Eggs, UPC 0 79307-00516 2. 19. Country Morning Extra Large 12 Eggs, Net Wt 27 oz (1lb 11oz) 766g, UPC 0 78566-00102 1. 20. Country Morning Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 78566-00101 4. 21. Cal-Maine Sunups 2 1/2 Dozen Eggs, UPC 0 28621-30498 7. Packed by Tx Lic #s. 0840962, 0840961 MPS Egg Farms, 2750 County Road 1011, Center, TX 75935. Bulk Product packaged as follows: 22. Medium Grade A JD 183, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 23. Medium Grade A JD 158, 30 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 24. Large Grade A JD 193, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 25. Large Grade A JD 193, 30 dozen MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 26. Grade A Large Egg JD 208, 900 dozen, Distributed by MPS Egg Farms, 14374 E Hwy 21, Byran, TX 77808. 27. Extra Large Grade A, JD 193, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 28. Jumbo Grade A, JD 175, 16.67 Dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. Keep Refrigerated at or Below 45-Degrees F.

Possible Salmonella Enteritidis

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

CGMP Deviations:Noted during FDA inspection

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.