Recall Z-0242-2015
Customed, Inc · initiated October 8, 2014
Class I – dangerous or defective products that could cause serious health problems or death
Product
Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Codes / lots: Lot numbers: 111102823 111112980 111123314 111123440 112020308 112020361 112030826 112041369 112041434 112051646 112062317 112083160 112093741 112104363 112124894 113015487 113035832 113046996 113047144 113057604 113057810 113078456 113078674 113089014 113109706 131110154 131110288 131210677 140111108 140211531 140312046 140412578 140513065 140613570 140714155 140714430 140814942
Reason for recall
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
FDA-determined cause: Packaging
Action taken
Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.
Details
- Recall number
- Z-0242-2015
- Initiated
- October 8, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- August 14, 2017
- Product code
- NXA – Tracheotomy Care Kit
- Quantity
- 78600
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Recalling firm
- Customed, Inc, Fajardo
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0237-2015 Class I | Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0238-2015 Class I | Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0239-2015 Class I | Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0240-2015 Class I | Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0241-2015 Class I | Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0243-2015 Class I | Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0244-2015 Class I | Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0245-2015 Class I | Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0246-2015 Class I | Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0247-2015 Class I | Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0248-2015 Class I | Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0249-2015 Class I | Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0250-2015 Class I | Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0251-2015 Class I | Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0252-2015 Class I | Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0253-2015 Class I | Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0254-2015 Class I | Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0255-2015 Class I | Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0256-2015 Class I | Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0257-2015 Class I | Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0258-2015 Class I | Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0259-2015 Class I | Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0260-2015 Class I | Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0261-2015 Class I | Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0262-2015 Class I | Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0263-2015 Class I | Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0264-2015 Class I | Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0265-2015 Class I | Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0266-2015 Class I | O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |
| Z-0267-2015 Class I | Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | 10/08/2014Terminated |