Recall Z-2294-2010 ยท DYB Introducer, Catheter
Greatbatch Medical
Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pre
| Date | Aug 27, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray. |
| Root cause | Packaging |
| Action | Greatbatch Medical issued an "Urgent Medical Device Recall letter dated July 12, 2010 via email to consignees. The letter described the problem and affected device. Consignees were instructed to immediately discontinue distribution of the product and return the unused units to Greatbatch Medical and to notify their customers to immediately return unused units. For shipping assistance, questions or assistance in notifying accounts, contact Shannon Springer at 763 951-8244 or Kimberly Briggs, 716 759-5702. |
| Quantity | 211 5-pack boxes |
| Distribution | Worldwide Distribution: United States, including the states of MN and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER Great Batch Medical, Mar 15, 2010 |