Reported Mar 20, 2013 · Terminated
GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One…
Symbios Medical Products, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Symbios Medical Products, LLC · 7301 Georgetown Rd. · Indianapolis, IN · 46268
Is this the product you have?
- GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump
- part number 510076One 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
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published 510112-BPlot 12-100983, 12-100984, 12-101096, 12-101125 Kit — lot 12-101110, 12-101103 Kit: 510401-BP — lot 12-101045 Kit: 510644 510076lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump — Lot Number: 12-100601 - Amount recalled
- 458
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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