Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubin
FDA device recall Z-2027-2011 · posted 2011-04-19 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
- Action taken
- The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at (ProductComplaintsPP@hospira.com).
- Root cause
- Other
- Status
- Terminated
- Product code
- KDC
- Quantity affected
- 61,150 sets
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.
- Date initiated
- 2011-03-28
- Date posted
- 2011-04-19
- Date terminated
- 2012-05-09
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING (K103224) | Hospira, Inc. | 2011-01-07 |