Recall Z-1955-2014
Medical Action Industries Inc · initiated June 12, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Codes / lots: Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.
Reason for recall
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.
Details
- Recall number
- Z-1955-2014
- Initiated
- June 12, 2014
- Posted by FDA
- July 1, 2014
- Terminated
- February 3, 2015
- Product code
- OVN – Suture Kit
- Quantity
- 474 cs (9,480 ea) total for all kits involved
- Distribution
- Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
- Recalling firm
- Medical Action Industries Inc, Arden, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1950-2014 Class II | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |
| Z-1951-2014 Class II | Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |
| Z-1952-2014 Class II | Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |
| Z-1953-2014 Class II | Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |
| Z-1954-2014 Class II | Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |
| Z-1956-2014 Class II | McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |
| Z-1957-2014 Class II | Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action…Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | 06/12/2014Terminated |