—#126148

Product

LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K982159
Affected lot / code info: Product List Number: 112410403; Lot Numbers: 280055H, 341005H

Why it was recalled

Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Hospira sent a URGENT MEDICAL DEVICE RECALL letter dated February 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) check their inventory and immediately quarantine any affected product; 2) complete the attached reply form and return it to the fax number or e-mail address on the form; 3) inform potential users within the direct account's organization of this product of the recall; 4) return affected products to Stericycle using labels provided with the notification; and 5) follow the instructions on the return label for returning products. Additional labels and guidance on returning products can be obtained by calling Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET). If the recalled products were further distributed, the recall notification documents should be forwarded to those accounts. Those accounts can contact Stericycle at 1-888-240-4282 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain a reply form and guidance on the return process.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.

Timeline

Recall initiated: 2014-02-25
Posted by FDA: 2014-04-21
Terminated: 2016-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.