APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catal
FDA device recall Z-0192-05 · posted 2004-11-11 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- rotating knob of the rotary style APL valve can become separated from the assembly.
- Action taken
- The recalling firm issued a letter to their accounts informing them of the problem. The letter also informed the accounts that they would be contacted when the replacement knob was available to schedule the correction.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 2321 units
- Distribution
- The product was shipped to medical supply companies, medical facilities nationwide. The product was also shipped to a government accounts in AR, FL, ID, LA, MA, MD, ME, NC, NY, OH, TX, VA, and VT. The
- Date initiated
- 2004-09-15
- Date posted
- 2004-11-11
- Date terminated
- 2007-06-19
- Location
- Telford, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC REFERENCE DATABASE (K041266) | Hologic, Inc. | 2004-08-11 |
| NARKOMED 6400, MODEL NM6400 (K033498) | Draeger Medical, Inc. | 2004-04-26 |