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Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo...
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Potential presence of Salmonella.
Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isop...
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Neon wall lamp
The product doesn’t comply with the mandatory standards for products containing button/coin batteries . The product was not tested prior to sale and is missing warning information about the dangers of button/coin batteries to children what to do when a person suspects someone has swallowed or placed a button/coin battery inside any part of their body.
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), ...
Potential Salmonella contamination
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide ...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Num...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye...
Lack of Assurance of Sterility
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient speci...
Incorrect product formulation: bag did not contain copper and famotidine per label.
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephi...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, ...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (...
Subpotent Drug
fabriqué sur place - croissant au jambon
mise en évidence de la présence de listeria monocytogenes