FDA Recall Terminated

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.

Recall: Z-0729-2008 · Initiated October 26, 2007

Recall

Recall Number
Z-0729-2008
Event Number
46155
Firm
Tri-State Hospital Supply Corporation
FEI Number
1824619
Product Code
LRP
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
October 26, 2007
Posted
February 23, 2008
Terminated
March 13, 2008
Address
301 Catrell Drive, Howell, MI, 48843

Description

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.

Reason

Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.

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.

Distribution

Nationwide Distribution, including states of Massachusetts and Washington.

Quantity

40 kits.