• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

  • Print
  • Share
  • E-mail
-

Product Detail

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
Recall Number Z-0940-2013
Classification Class I
Code Info 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
Product Distributed Qty 458
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.

Event Detail

Event Id 64423
Product Type Devices
Status Ongoing
Recalling Firm Symbios Medical Products, LLC
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
-
-