Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood prod
FDA device recall Z-0817-2012 · posted 2012-01-19 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container.
- Action taken
- The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated January 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and immediately quarantine any affected product. Additionally, a Reply Form was attached for customers to complete and return via fax to 1-866-912-8410 or e-mail to: hospira2573@stericycle.com. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 960 units
- Distribution
- Distributed in the states of North Carolina and Washington.
- Date initiated
- 2012-01-12
- Date posted
- 2012-01-19
- Date terminated
- 2016-08-29
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA INFUSION BLOOD SETS (K101677) | Hospira, Inc. | 2010-08-11 |