BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is des
FDA device recall Z-1948-2009 · posted 2009-09-06 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Product sterility may be compromised due to lack of package integrity.
- Action taken
- Davol issued a Recall Letter dated July 30, 2009 requesting user facilities examine inventory and immediately discontinue use of any product from the affected lot and return it to Davol. Direct questions about the recall to Davol, Inc., Sub. C. R. Bard, Inc. by calling 1-401-463-7000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FHQ
- Quantity affected
- 1,140 units
- Distribution
- Nationwide.
- Date initiated
- 2009-07-30
- Date posted
- 2009-09-06
- Date terminated
- 2016-08-17
- Location
- Warwick, RI
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