Customed, Inc: MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Recall number

Z-2606-2015

Recalling firm

Customed, Inc

Product

MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Status

Terminated

Initiated

2015-07-10

Posted

2015-09-03

Terminated

2017-04-12

Reason

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

Root cause

Packaging

Action

Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Quantity

945

Distribution

Distributed Only in Puerto Rico.

Lot, serial or model codes

Code:9001735 Lots: 140814973 exp. 11/30/15 141015733 exp. 10/31/15 141216417 exp. 12/31/15 141216417 exp. 12/31/15 150217361 exp. 2/28/16 150217362 exp. 2/28/16 150217363 exp. 2/28/16 150217364 exp. 2/28/16 150418267 exp. 4/30/16 150418266 exp. 4/30/16 150518660 exp. 5/16/16 150518661 exp. 5/31/16

510(k) numbers

["K902886"]

PMA numbers

not on file

Product code

LRO

Firm FEI

2648727

Firm city

Fajardo

Firm state

not on file

Firm country

PR

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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