FDA Medical Device Recalls (openFDA)
Customed, Inc: MAJOR LAP 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-2673-2015
- Recalling firm
- Customed, Inc
- Product
- MAJOR LAP 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
- 2736
- Distribution
- Distributed Only in Puerto Rico.
- Lot, serial or model codes
- Code:900404 Lots: 140915488 exp. 10/31/15 141216330 exp. 12/31/15 141216438 exp. 12/31/15 141216438 exp. 12/31/15 150116533 exp. 2/28/16 150116807 exp. 2/28/16 150116808 exp. 2/28/16 150116809 exp. 2/28/16 150116810 exp. 2/28/16 150116811 exp. 2/28/16 150217401 exp. 2/28/16 150217402 exp. 2/28/16 150217404 exp. 2/28/16 150217405 exp. 2/28/16 150217403 exp. 2/28/16 150217406 exp. 2/28/16 150217407 exp. 2/28/16 150217408 exp. 2/28/16 150217409 exp. 2/28/16 150317803 exp. 3/31/16 150317805 exp. 3/31/16 150317808 exp. 3/31/16 150317807 exp. 3/31/16 150317809 exp. 3/31/16 150317806 exp. 3/31/16 150418397 exp. 4/30/16 150418398 exp. 4/30/16 150418399 exp. 4/30/16 150418400 exp. 4/30/16 150418499 exp. 4/30/16 150418500 exp. 4/30/16 150418501 exp. 4/30/16 150418498 exp. 4/30/16 150519002 exp. 5/31/16 150519004 exp. 6/30/16 150519003 exp. 6/30/16 150519005 exp. 6/30/16 150619464 exp. 6/30/16 150619463 exp. 6/30/16 150619385 exp. 6/30/16 150619466 exp. 6/30/16
- 510(k) numbers
- ["K902031"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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