AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, pol
FDA device recall Z-1009-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Sterility compromised due to breach in sterile barrier
- Action taken
- Covidien notified customers via letter dated November 15, 2010. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to examine inventory and return the affected lot to Field Returns Department, 195 McDermott Road, North Haven, CT 06473. For questions regarding this recall call 203-492-8091.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 132 units
- Distribution
- Worldwide Distribution - USA including CA, CT, FL, HI, IL, IN, KS, MA, MD, MI, MN, NC, NJ, NY, OH, PA, SC, TX, and WI and the countries of Canada and Italy
- Date initiated
- 2010-12-15
- Date posted
- 2011-02-01
- Date terminated
- 2013-01-10
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH (K915526) | United States Surgical, A Division of Tyco Healthc | 1992-05-29 |