Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek
FDA device recall Z-2286-2010 · posted 2010-08-26 · Terminated
Recall details
- Recalling firm
- Telefelx Medical
- Reason for recall
- Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.
- Action taken
- Teleflex Medical issued consignees a "Urgent Medical Device Recall" letter dated February 1, 2010. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. The letter described the packaging issue and potential impact. Customers were instructed to immediately discontinue use and quarantine any identified products, complete and fax the Recall Acknowledgement Form to 866-804-9881, in order to receive a Return Goods Authorization (RGA) Number, and then return the product to Teleflex Medical for replacement. Affected products received by Teleflex Medical will be destroyed upon receipt.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 17 sales units (24 packs per sales unit/408 units)
- Distribution
- Worldwide Distribution: USA and Germany
- Date initiated
- 2010-02-01
- Date posted
- 2010-08-26
- Date terminated
- 2011-04-19
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE (K905482) | Pfizer Hospital Products Group, Inc. | 1991-03-14 |