Recall Z-0590-2011 ยท LWE Bone Marrow Collection/Transfusion Kit
Orthofix Inc
Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.
| Date | Dec 10, 2010 (initiated Oct 18, 2010) |
| Status | Terminated |
| Reason | Outer cartons for the product may be labeled with incorrect needle gauge. |
| Root cause | Other |
| Action | Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061. |
| Quantity | 274 |
| Distribution | Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913306 | BONE-TEMNO/STERNUM-TEMNO Proact, Ltd., Nov 1, 1991 |