Recall Z-2027-2011 ยท KDC Instrument, Surgical, Disposable
Hospira Inc.
Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 13744-28 For epidural administration of fluids with the Gemstar Pump
| Date | Apr 19, 2011 (initiated Mar 28, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 St |
| Quantity | 61,150 sets |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING Hospira, Inc., Jan 7, 2011 |