Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-
FDA device recall Z-2075-2012 · posted 2012-07-25 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The float valve in the burette sticks to the burette wall and does not open or close properly.
- Action taken
- The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated July 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-877-722-7019 or e-mail to: hospira4921@stericycle.com; return affected product to Stericycle using the label provided with the letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 4,420 sets
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Was
- Date initiated
- 2012-07-13
- Date posted
- 2012-07-25
- Date terminated
- 2016-11-28
- 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 |
|---|---|---|
| HOSPIRA INFUSION BLOOD SETS (K101677) | Hospira, Inc. | 2010-08-11 |