AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used t
FDA device recall Z-0319-2009 · posted 2008-12-05 · Terminated
Recall details
- Recalling firm
- Mindray DS USA, Inc., dba Datascope Patient Monitoring
- Reason for recall
- Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate
- Action taken
- Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 2 units
- Distribution
- Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
- Date initiated
- 2008-10-07
- Date posted
- 2008-12-05
- Date terminated
- 2008-12-08
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 (K080175) | Datascope Corp., Patient Monitoring Division | 2008-06-09 |