FDA Device recall Z-2612-2015

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

FDA Device
Class II
terminated
Published 2015-09-09

On 2015-09-09 the FDA classified a Class II recall of OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal… 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-2612-2015
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

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

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:9001780 Lots: 141015756 exp. 9/30/16 141216419 exp. 12/31/16 150116978 exp. 2/28/16 150317700 exp. 4/30/16 1… Code:9001780 Lots: 141015756 exp. 9/30/16 141216419 exp. 12/31/16 150116978 exp. 2/28/16 150317700 exp. 4/30/16 150317701 exp. 4/30/16 150317702 exp. 4/30/16 150518592 exp. 6/30/16 150518593 exp. 6/30/16 150518594 exp. 6/30/16 150518594 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-2612-2015%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.