Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

FDA device recall Z-1269-2020 · posted 2020-01-27 · Terminated

Recall details

Recalling firm

TELEFLEX MEDICAL INC

Reason for recall

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DWS

Quantity affected

1764 units

Distribution

Worldwide

Date initiated

2020-01-13

Date posted

2020-01-27

Date terminated

2021-11-24

Location

Morrisville, NC