FDA Medical Device Recalls (openFDA)
Customed, Inc: SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Recall number
- Z-2549-2015
- Recalling firm
- Customed, Inc
- Product
- SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform 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
- 20200 kits
- Distribution
- Distributed Only in Puerto Rico.
- Lot, serial or model codes
- Catalog number: 900010 Lots: 141015851 exp. 10/31/2015 150116710 exp.1/31/2016 150117001 exp.2/28/2016 150317560 exp.3/31/2016 150317560 exp.3/31/2016 150418252 exp.5/31/2016 150418252 exp.5/31/2016 150518605 exp.5/31/2016 150518605 exp.5/31/2016
- 510(k) numbers
- ["K925015"]
- PMA numbers
- not on file
- Product code
- MCZ
- 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