Recall Z-0730-2008 ยท KDC Instrument, Surgical, Disposable
Tri-State Hospital Supply Corporation
Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospital Supply Co., Howell, MI. 48844. The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size.
| Date | Feb 23, 2008 (initiated Oct 26, 2007) |
| Status | Terminated |
| Reason | Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label. |
| Root cause | Mixed-up of materials/components |
| Action | An Urgent Product Recall Notice was sent on October 25, 2007 to Distributors, Distributors customers, and all third party consignee. The letter provided information concerning the product recall, and requested removal of all product inventory. A product return form requesting information on products still in the facility was enclosed. A Tri-State Representative will be in contact regarding retrieval of the product. |
| Quantity | 396 kits. |
| Distribution | Nationwide Distribution, including states of Massachusetts and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012736 | MONOJECT SAFETY NEEDLE Tyco Healthcare, Oct 25, 2001 |