Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-0
FDA device recall Z-2294-2010 · posted 2010-08-27 · Terminated
Recall details
- Recalling firm
- Greatbatch Medical
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 211 5-pack boxes
- Distribution
- Worldwide Distribution: United States, including the states of MN and CA.
- Date initiated
- 2010-07-02
- Date posted
- 2010-08-27
- Date terminated
- 2011-12-17
- Location
- Minneapolis, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER (K093232) | Great Batch Medical | 2010-03-15 |