GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
FDA Recall Z-0015-2010 · Posted 2009-10-06
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Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2009-08-11
Date Terminated2010-11-30
Product Quantity204,999 total
Reason for Recall
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
Firm Action
Firm initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and an Urgent: Device Field Correction letter to consignees was sent via UPS. The letter recommended that customers check their infusion pumps and spare parts in their inventory to determine if the specified AC Power Cords are in use at their facility; and, to inspect the affected cords for bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear. Also, it was recommended that customers immediately discontinue use of the affected cords exhibiting the described characteristics and contact their local Hospira representative for assistance. The letter stated that customers may continue to use and monitor cords that are not exhibiting the described characteristics until replacement cords are sent to their facility. Hospira will contact customers to schedule replacement. Customers are to complete and return the attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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