FDA Medical Device Recalls (openFDA)
TELEFLEX MEDICAL INC: Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
- Recall number
- Z-1269-2020
- Recalling firm
- TELEFLEX MEDICAL INC
- Product
- Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
- Status
- Terminated
- Initiated
- 2020-01-13
- Posted
- 2020-01-27
- Terminated
- 2021-11-24
- Reason
- There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall by letter on 01/13/2020. The actions to be taking be the consignees are as follows: Check inventory. If affected stock is found, discontinue use immediately and quarantine. Complete the acknowledgement form as soon as possible indicating whether you do or do not have stock and fax it 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. For additional questions, contact the local sales representative or Customer Service at 1-866-396-2111.
- Quantity
- 1764 units
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot Number 74B1500674
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWS
- 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