Recall Z-1264-2012
Customed, Inc · initiated December 8, 2011
Product
Wound Management Tray Asoc. Agencia Salud, catalog# 900-1154
Codes / lots: lot# 111010025, 111020497, 111030548, 111041068, 111061631, 111102825
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.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-1264-2012
- Initiated
- December 8, 2011
- Posted by FDA
- March 21, 2012
- Terminated
- April 12, 2017
- Product code
- MCY – Wound Dressing Kit
- Quantity
- 7,656 units
- Distribution
- USA Nationwide Distribution - including Florida and Puerto Rico.
- Recalling firm
- Customed, Inc, Fajardo
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1251-2012 | Suture removal kit, catalog# 900-010The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1252-2012 | Irrigation Tray w/Bulb syringe, catalog# 900-020The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1253-2012 | Prep shave kit, catalog# 900-030The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1254-2012 | Universal drainage kit, catalog# 900-032The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1255-2012 | Tracheotomy care kit, catalog# 900-110The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1256-2012 | Suction Catheter Kit, catalog# 900-277The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1257-2012 | Urethral Catheter Tray catalog# 900-278The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1258-2012 | Incision and Drainage Tray, catalog# 900-774The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1259-2012 | Skin Stapler Removal Kit , catalog# 900-782The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1260-2012 | Minor laceration tray , catalog# 900-1765The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1261-2012 | Wound Closure Tray I, catalog# 900-063The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1262-2012 | Wound Closure Tray II, catalog# 900-064The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1263-2012 | Wound Management Tray, catalog# 900-540The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1265-2012 | Wound Management Tray, catalog# 900-1456The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1266-2012 | Wound Management Ryder, catalog# 900-1605The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |
| Z-1267-2012 | Wound Management Tray Aten cion med. EN El Hogar, catalog# 900-1903The firm has determined that there is a possibility that packaging seals may be compromised. The issue could… | 12/08/2011Terminated |