Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch ,
FDA device recall Z-0292-2012 · posted 2011-11-25 · 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 November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: hospira2530@stericycle.com; return affected product to Stericycle using the label provided with this 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
- 12,580 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: Alabama, Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Mis
- Date initiated
- 2011-11-10
- Date posted
- 2011-11-25
- Date terminated
- 2016-12-15
- 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 |