Reported Jun 12, 2013 · Terminated
Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits…
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?
- Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
- Lot codes and dates
- Pump Part 510613
- Lot 11-100136- Lot 12-10101060 found in
GoBlock Kit 510612Lot 11-100817 to 13-101475
- Amount recalled
- 33,543 all kits
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
Using this product could cause serious injury, illness or death — stop using it now.
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