Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, con
FDA device recall Z-0506-06 · posted 2006-02-08 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
- Action taken
- Hospira notified all of their customers who purchased these list numbers within the last year via letter dated 1/9/06, informing them of the diversion of the affected lots of product prior to being sterilized and that use of the lots could result in the delivery of fluids through a non-sterile pathway. They requested the accounts to check their stocks of the affected list numbers for the list lot numbers. If any of the lots are found in stock, they were requested to place them in quarantine immediately and call Hospira Customer Care at 1-877-946-7747.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 60 sets
- Distribution
- The lots were not released or distributed by Hospira
- Date initiated
- 2006-01-09
- Date posted
- 2006-02-08
- Date terminated
- 2006-07-20
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISP. TRANSDUCER W/MONITORING KIT TRANS (K831506) | Sorensen Research | 1983-08-12 |
| DISPOSABLE TRANSDUCER (K813464) | Sorensen Research | 1982-01-07 |