Recall Z-0940-2013— Symbios Medical Products, LLC

Name: FDA recall Z-0940-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-25

Class I · Terminated

Class I FDA medical device recall by Symbios Medical Products, LLC, initiated 2013-02-25, terminated 2014-02-13. It names one FDA 510(k) clearance: K072921. Product: 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: 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..

Recalling firm: Symbios Medical Products, LLC
Classification: Class I
Status: Terminated
Initiated: 2013-02-25
Terminated: 2014-02-13
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEMSymbios Medical Products, LLC·cleared 2007-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.