Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A
USBrand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A
Recalling Firm: TELEFLEX LLC
Reason for Recall / Hazard
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Product Description & Identification
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A
Affected Products
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A
Additional Source Details
| Field | Value |
|---|---|
| City | Morrisville |
| State | NC |
| Event id | 98962 |
| Address 1 | 3015 Carrington Mill Blvd |
| Address 2 | N/A |
| Code info | Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1/2" X-Ray Detectable Catalog Number: 200100 UDI codes: (01)2 4026704 41748 7(17)260521(11)210521(10)21E1485 (01)2 4026704 41748 7(17)260811(11)210811(10)21H2304 (01)2 4026704 41748 7(17)260906(11)210906(10)21H2594 (01)2 4026704 41748 7(17)260906(11)210906(10)21H2595 (01)2 4026704 41748 7(17)261018(11)211018(10)21K3161 (01)2 4026704 41748 7(17)261130(11)211130(10)21L3593 (01)2 4026704 41748 7(17)270203(11)220203(10)22A0175 (01)2 4026704 41748 7(17)270316(11)220316(10)22C0661 (01)2 4026704 41748 7(17)270512(11)220512(10)22E1386 (01)2 4026704 41748 7(17)270915(11)220915(10)22J2777 (01)2 4026704 41748 7(17)271019(11)221019(10)22K3102 (01)2 4026704 41748 7(17)271027(11)221027(10)22K3269 (01)2 4026704 41748 7(17)271031(11)221031(10)22K3270 (01)2 4026704 41748 7(17)280124(11)230124(10)23A0102 (01)2 4026704 41748 7(17)280405(11)230405(10)23D0796 (01)2 4026704 41748 7(17)280426(11)230426(10)23D0900 (01)2 4026704 41748 7(17)280530(11)230530(10)23... [TRUNCATED] |
| Postal code | 27560-5437 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 1488700 |
| Reason for recall | Due to out-of-specification, or potential out-of-specification, levels of endotoxins |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260507 |
| Initial firm notification | N/A |
| Center classification date | 20260701 |
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Overview
- Recalling FirmTELEFLEX LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama.
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🚨 SAFETY ALERT: TELEFLEX LLC - Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A Check if your household is affected: https://therecallfile.com/recalls/brand-name-pilling-wecksorb-product-name-pilling-wecksorb-neurosponges/FDA-Z-2639-2026
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