Z-1258-2012

Incision and Drainage Tray, catalog# 900-774

Name: Z-1258-2012 Incision and Drainage Tray, catalog# 900-774
Creator: Customed, Inc
Published: 2011-12-08
License: https://open.fda.gov/license/

Customed, Inc / initiated 2011-12-08 / Terminated / root cause: packaging

FDA source

Customed, Inc began a recall of Incision and Drainage Tray, catalog# 900-774 on 2011-12-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1258-2012
Status: Terminated
Initiated: 2011-12-08
Posted: 2012-03-21
Terminated: 2017-04-12
Recalling firm: Customed, Inc
Product: Incision and Drainage Tray, catalog# 900-774
Product code: FSM Tray, Surgical, Instrument
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 1,650 units
Distribution: USA Nationwide Distribution - including Florida and Puerto Rico.
Product codes and lots: lot# 111030722, 111061688

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)