Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical c
FDA device recall Z-2328-2009 · posted 2009-09-30 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- Reason for recall
- It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
- Action taken
- Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 2552
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-04-22
- Date posted
- 2009-09-30
- Date terminated
- 2010-02-25
- Location
- East Windsor, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (K001387) | I-Stat Corp. | 2000-10-05 |