Customed, Inc: UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Recall number

Z-2592-2015

Recalling firm

Customed, Inc

Product

UROLOGY PACK 4/CS 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

352

Distribution

Distributed Only in Puerto Rico.

Lot, serial or model codes

Code:9001521 Lots: 141015699 exp. 11/30/15 141115980 exp. 12/31/15 150116560 exp. 2/28/16 150116560 exp. 2/28/16 150217271 exp. 2/28/16 150317613 exp. 4/30/16 150317616 exp. 4/30/16 150317615 exp. 4/30/16 150518646 exp. 5/31/16 150418301 exp. 5/31/16 150518647 exp. 5/31/16 150418302 exp. 5/31/16 150619387 exp. 6/30/16

510(k) numbers

["K962652"]

PMA numbers

not on file

Product code

KNX

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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