Home / Recalls / Symbios Medical Products, LLC / Z-0940-2013

Z-0940-2013 Class I Terminated

Recalled by Symbios Medical Products, LLC — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
March 20, 2013
Initiation Date
February 25, 2013
Termination Date
February 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
458

Product Description

GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management

Reason for Recall

Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.

Distribution Pattern

Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.

Code Information

Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125 Kit Part Number 510112-BP, lot 12-101110, 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump Part Number: 510076 Lot Number: 12-100601

Other recalls by Symbios Medical Products, LLC

  • Z-1453-2013 Class I — Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 m (May 10, 2013)
  • Z-1459-2013 Class I — Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per s (May 10, 2013)
  • Z-1455-2013 Class I — Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...st (May 10, 2013)
  • Z-1458-2013 Class I — Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),.. (May 10, 2013)
  • Z-1461-2013 Class I — Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( (May 10, 2013)
  • Z-1460-2013 Class I — Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( (May 10, 2013)
  • Z-1462-2013 Class I — Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml persi (May 10, 2013)
  • Z-1454-2013 Class I — Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/h (May 10, 2013)
  • Z-1452-2013 Class I — Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME (May 10, 2013)
  • Z-1456-2013 Class I — Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side, (May 10, 2013)