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FDA Medical Device Recalls (openFDA)

Covidien LLC: Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.

Recall number
Z-1304-2013
Recalling firm
Covidien LLC
Product
Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
Status
Terminated
Initiated
2013-04-12
Posted
2013-05-11
Terminated
2015-06-02
Reason
On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.
Root cause
Error in labeling
Action
US Customers were notified of the recall by letter sent by Federal Express on April 12, 2013. The letter requests that they immediately stop using any affected product, quarantine it, and return it to Covidien. Consignees were asked to return a verification form and return it to Covidien via fax.
Quantity
52363 distributed
Distribution
Worldwide distribution: USA (nationwide) and in the country of: Panama.
Lot, serial or model codes
103387264, 117881264, 110983964, 214981164, 117488864
510(k) numbers
["K761193"]
PMA numbers
not on file
Product code
KDD
Firm FEI
1282497
Firm city
Mansfield
Firm state
MA
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

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