Z-1269-2020Class II

Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

Name: Z-1269-2020 Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Creator: Teleflex Medical Inc
Published: 2020-01-13
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2020-01-13 / Terminated / root cause: packaging

FDA source

TELEFLEX MEDICAL INC began a recall of Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 on 2020-01-13. FDA classified it as Class II and gives the reason as "There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1269-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Posted: 2020-01-27
Terminated: 2021-11-24
Recalling firm: Teleflex Medical
Product: Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Root cause tag: packaging
FDA 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 [email protected]. 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 in commerce: 1764 units
Distribution: Worldwide
Product codes and lots: Lot Number 74B1500674

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1269-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1269-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1270-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)