Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
FDA device recall Z-0909-2023 · posted 2023-01-06 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Action taken
- On December 2, 2022, the firm notified customers via "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letters. Customers were instructed to immediately remove units of affected product from service. Customers should complete the Acknowledgement Form and return to the recalling company. Once received, Customer Service will contact the customer to aid them in returning the affected product. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HBA
- Quantity 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, Roma
- Date initiated
- 2022-12-02
- Date posted
- 2023-01-06
- Location
- Princeton, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Codman Surgical Patties & Strips (K193346) | Integra LifeSciences Corporation | 2020-11-20 |