FDA Medical Device Recalls (openFDA)
Customed, Inc: LAPAROTOMY SURGICAL PACK 3/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-2657-2015
- Recalling firm
- Customed, Inc
- Product
- LAPAROTOMY SURGICAL PACK 3/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
- 1866
- Distribution
- Distributed Only in Puerto Rico.
- Lot, serial or model codes
- Code:900281A Lots: 140814951 exp. 2/28/16 140714543 exp. 2/28/16 141015713 exp. 10/31/15 150116503 exp. 12/31/15 150116513 exp. 12/31/15 150116514 exp. 12/31/15 150116515 exp. 12/31/15 141216437 exp. 12/31/15 150116939 exp. 2/28/16 150116940 exp. 2/28/16 150116938 exp. 2/28/16 150116941 exp. 2/28/16 150116937 exp. 2/28/16 150317732 exp. 3/31/16 150317731 exp. 3/3/16 150317734 exp. 3/31/16 150317733 exp. 3/31/16 150317954 exp. 4/30/16 150317957 exp. 4/30/16 150317958 exp. 4/30/16 150317959 exp. 4/30/16 150317960 exp. 4/30/16 150317961 exp. 4/30/16 150418383 exp. 4/30/16 150418384 exp. 4/30/16 150418385 exp. 4/30/16 150518790 exp. 5/31/16 150519028 exp. 5/31/16 150519029 exp. 5/31/16
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 2648727
- Firm city
- Fajardo
- Firm state
- not on file
- Firm country
- PR
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