CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
- Company
- Custom Medical Specialties, Inc.
- Recall Initiated
- September 30, 2011
- Posted
- September 7, 2012
- Terminated
- September 10, 2012
- Recall Number
- Z-2329-2012
- Quantity
- 16 cases
- Firm Location
- Pine Level, NC
Reason for Recall
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Distribution
Nationwide Distribution including GA, MI, NY, and PA.
Lot / Code Info
16480-0908, 20976-1008, 21283-1009
Root Cause
Nonconforming Material/Component
Action Taken
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated August 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory for the affected product and to discontinue the use of any affected product. Customer were instructedto complete and return the Return Response form, acknowledging they have received the letter and checked their inventory. Any product still in the customers inventory should be returned to the firm. Customers should call (919) 202-8462, ext 205 to obtain a Return Authorization Number and the shipping number. For questions regarding this recall call 919-202-8462.