Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Reported: January 18, 2023 Initiated: December 2, 2022 #Z-0909-2023
Product Description
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Reason for Recall
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 168 US; 3 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457. Recalled by Integra LifeSciences Corp.. Units affected: 168 US; 3 OUS.
Why was this product recalled? ▼
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0909-2023.
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