Recall Z-0237-2015
Customed, Inc · initiated October 8, 2014
Class I – dangerous or defective products that could cause serious health problems or death
Product
Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Codes / lots: Lot numbers 111102811 111112953 111112969 111123257 111123438 112010003 112020291 112030762 112041051 112041384 112051641 112051718 112062298 112072758 112083040 112104122 112104289 112114540 112124364 112124885 113025838 113026102 113026206 113057390 113057682 113099556 131010023 131210663 140111103 140412874 140513047 140513388 140613946 140714499 140815022
Reason for recall
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes (QSR) 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-0237-2015
- Initiated
- October 8, 2014
- Posted by FDA
- December 16, 2014
- Terminated
- August 14, 2017
- Product code
- MCZ – Suture Removal Kit
- Quantity
- 185000
- 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-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-0242-2015 Class I | Tracheotomy Care Kit, Catalog number 900-110. 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 |