FDA Device recall Z-2713-2015

CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…

FDA Device
Class II
terminated
Published 2015-09-09

On 2015-09-09 the FDA classified a Class II recall of CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,… by Customed, citing recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2713-2015
Classification	Class II
Status	terminated
Initiated	2015-07-10
Published	2015-09-09
Last updated	2026-09-13 11:53 UTC
Company	Customed
Distribution	PR

Product

CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Reason

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Identifiers

code_info	Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16… Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16 150116828 exp. 2/28/16 150116829 exp. 2/28/16 150317866 exp. 4/30/16 150317867 exp. 4/30/16 150317868 exp. 4/30/16 150317869 exp. 4/30/16 150418428 exp. 4/30/16 150418426 exp. 4/30/16 150418427 exp. 4/30/16 150418585 exp. 5/31/16 150418586 exp. 5/31/16 150619298 exp. 6/30/16 150619299 exp. 6/30/16

code_info

Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16…

Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16 150116828 exp. 2/28/16 150116829 exp. 2/28/16 150317866 exp. 4/30/16 150317867 exp. 4/30/16 150317868 exp. 4/30/16 150317869 exp. 4/30/16 150418428 exp. 4/30/16 150418426 exp. 4/30/16 150418427 exp. 4/30/16 150418585 exp. 5/31/16 150418586 exp. 5/31/16 150619298 exp. 6/30/16 150619299 exp. 6/30/16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2713-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.