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.
FDA Recall Z-0729-2008 · Posted 2008-02-23
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Recalling FirmTri-State Hospital Supply Corporation
Recall StatusTerminated
Product CodeLRP
Date Initiated2007-10-26
Date Terminated2008-03-13
Product Quantity40 kits.
Reason for Recall
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.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide Distribution, including states of Massachusetts and Washington.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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