LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hosp
FDA device recall Z-1491-2012 · posted 2012-05-04 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention.
- Action taken
- Hospira, sent an "URGENT DEVICE RECALL" letter dated April 25, 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 to return for credit. A Reply Form was enclosed for customers to complete and return via fax to 1-888-386-2073 or e-mail to: Hospira8503@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for information regarding product availability.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 145,875 sets
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: Alabama, Colorado, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, North Carolina
- Date initiated
- 2012-04-25
- Date posted
- 2012-05-04
- 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 |
|---|---|---|
| I.V. SET WITH DUAL-CHANNEL CASSETTE (K865060) | Abbott Laboratories | 1987-02-06 |