Reported Dec 9, 2015 · Terminated
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model…
Quest Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Quest Medical, Inc. · 1 Allentown Pkwy · Allen, TX · 75002-4206
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
5001102 | MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing |
5001102-AS | MPS Delivery Set with 6 ft. delivery tubing |
7001102 | MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment. |
- Lot codes and dates
0491795E040492175E040492185E060492195E060492615E060492625E080492635E080489905Y040490245Y060493075U020493085U020493435U040493675U040493685U07494465U070494475U090494855G010495215U110495225U110495505G02495515G020496535G080496875G08496885G080497245S020495205U11497255S040497655S040498535S060498545S060492205E030493695U040494485U070495525G020497265S020495965G040492765E07
- Amount recalled
- 18,761 units
Where it was sold
- Nationwide
Why it was recalled
The products have been found to intermittently exhibit a seal failure during use.
This product could cause temporary or reversible health problems — stop using it.
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