FDA Medical Device Recalls (openFDA)
Customed, Inc: SURGICAL PACK 20/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-2627-2015
- Recalling firm
- Customed, Inc
- Product
- SURGICAL PACK 20/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
- 540
- Distribution
- Distributed Only in Puerto Rico.
- Lot, serial or model codes
- Code:9002224 Lots: 141015709 exp. 2/28/16 141216301 exp. 12/31/15 150116523 exp. 1/31/16 150116524 exp. 1/31/16 150116525 exp. 1/31/16 150116526 exp. 1/31/16 150317725 exp. 4/30/16 150317726 exp. 4/30/16 150418352 exp. 4/30/16 150418351 exp. 4/30/16 150518686 exp. 5/31/16 150518687 exp. 5/31/16 150519027 exp. 6/30/16
- 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
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
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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