Recall Z-3107-2017 ยท LRO General Surgery Tray
Cardinal Health 200, LLC
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
| Date | Aug 14, 2017 (initiated Aug 1, 2017) |
| Status | Terminated |
| Reason | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection. |
| Root cause | Material/Component Contamination |
| Action | BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected customers. The firm requested the consignee cease use and segregate the products, complete and return the response form. Distributors were requested to notify their customers of the action. Customers with questions were instructed to call 201-847-4267. For questions regarding this recall call 800-292-9332. |
| Quantity | 184,102 kits |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.