FDA Medical Device Recalls (openFDA)
Customed, Inc: ANGIOGRAPHY PACK CUSTOMED 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-2622-2015
- Recalling firm
- Customed, Inc
- Product
- ANGIOGRAPHY PACK CUSTOMED 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
- 1128
- Distribution
- Distributed Only in Puerto Rico.
- Lot, serial or model codes
- Code:900210 Lots: 140915501 exp. 10/31/15 140915501 exp. 10/31/15 150116702 exp. 2/28/16 150116701 exp. 1/31/16 150116703 exp. 1/31/16 150116704 exp. 1/31/16 150116705 exp. 1/31/16 150116706 exp. 1/31/16 150217378 exp. 2/28/16 150217379 exp. 2/28/16 150217380 exp. 2/28/16 150217381 exp. 2/28/16 150217382 exp. 2/28/16 150317721 exp. 3/31/16 150317720 exp. 3/31/16 150318115 exp. 3/31/16 150318116 exp. 3/31/16 150318117 exp. 3/31/16 150318118 exp. 3/31/16 150418270 exp. 4/30/16 150418271 exp. 4/30/16 150418272 exp. 4/30/16 150418273 exp. 4/30/16
- 510(k) numbers
- ["K904694"]
- PMA numbers
- not on file
- Product code
- OEQ
- 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