FDA Medical Device Recalls (openFDA)
TELEFLEX LLC: Pilling Wecksorb Cylindrical Sponges
- Recall number
- Z-0772-2023
- Recalling firm
- TELEFLEX LLC
- Product
- Pilling Wecksorb Cylindrical Sponges
- Status
- Open, Classified
- Initiated
- 2022-09-28
- Posted
- 2022-12-28
- Terminated
- not on file
- Reason
- Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were notified on about 09/28/2022, via letter. Consignees were instructed to immediately discontinue use and quarantine the products on hand, complete and return the enclosed Acknowledgement Form via fax to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
- Quantity
- 1,000 units
- Distribution
- Domestic distribution to IL, MS, PA, TN.
- Lot, serial or model codes
- Catalog Number: 200400, Lot Number: 22B0395
- 510(k) numbers
- ["K791871"]
- PMA numbers
- not on file
- Product code
- EFQ
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28