FDAFDA · Food and drugs·Recall number Z-0940-2013
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
Published March 20, 2013 · Recall initiated: February 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Symbios Medical Products, LLC
- Distributor
- Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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