Z-0031-2010
Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA...
Abbott Medical / initiated 2009-08-11 / Terminated / root cause: design
Hospira Inc began a recall of Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan... on . The reason FDA records is "Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0031-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
- Product code
- FRN Pump, Infusion
- Reason for recall
- Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Root cause tag
- design
- FDA root cause
- Component design/selection
- 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.
- Quantity in commerce
- 204,999 total
- Distribution
- Worldwide Distribution
- Product codes and lots
- AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
