LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTI
FDA device recall Z-0195-06 · posted 2005-11-24 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
- Action taken
- Hospira sent product recall letters dated 5/6/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possiblitiy of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- BRZ
- Quantity affected
- 17,184 units
- Distribution
- Nationwide including Puerto Rico, and internationally to Mexico and Australia
- Date initiated
- 2005-05-06
- Date posted
- 2005-11-24
- Date terminated
- 2005-11-29
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESHIELD EXTENSION SET (K941214) | Abbott Mfg., Inc. | 1994-10-03 |
| IVEX-HP96 EXTENDED LIFE FILTER SET (K920736) | Abbott Laboratories | 1993-04-23 |
| HEMA - NV TRANS. BLOOD FILTER 100/800 (K830014) | Abbott Laboratories | 1983-01-17 |