FDA Medical Device Recalls (openFDA)
Customed, Inc: Minor laceration tray , catalog# 900-1765
- Recall number
- Z-1260-2012
- Recalling firm
- Customed, Inc
- Product
- Minor laceration tray , catalog# 900-1765
- Status
- Terminated
- Initiated
- 2011-12-08
- Posted
- 2012-03-21
- Terminated
- 2017-04-12
- Reason
- The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
- Root cause
- Packaging
- Action
- Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.
- Quantity
- 20,150 units
- Distribution
- USA Nationwide Distribution - including Florida and Puerto Rico.
- Lot, serial or model codes
- lot# 111010245, 111020332, 111020333, 111020506, 111030616, 111040994, 111051168, 111061621, 111071912, 111082098, 111092569
- 510(k) numbers
- ["K950295"]
- 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