Quest Medical MPS Delivery Sets Recalled for Intermittent Seal Failure
Quest Medical, Inc. is recalling specific MPS Delivery Sets used with cardiopulmonary bypass equipment due to intermittent seal failures during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (seal failure) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Quest Medical, Inc. is recalling 18,761 units of Model 5001102, Model 5001102-AS, and Model 7001102 MPS Delivery Sets. These products are used with cardiopulmonary bypass equipment and include components such as arrest agent and additive cassettes, heat exchangers, and delivery tubing.
The recall was initiated because the products have been found to intermittently exhibit a seal failure during use. The affected units were distributed nationwide in the United States as well as in Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
Healthcare facilities and users should stop using the affected delivery sets and contact Quest Medical, Inc. for further instructions or replacement. The specific lot codes affected are listed in the official recall documentation.
The recalled product
- Product
- Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
- Manufacturer
- Quest Medical, Inc.
- Hazard
- Affected units
- 18,761
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 0491795E04
- 0492175E04
- 0492185E06
- 0492195E06
- 0492615E06
- 0492625E08
- 0492635E08
- 0489905Y04
- 0490245Y06
- 0493075U02
- 0493085U02
- 0493435U04
- 0493675U04
- 0493685U07
- 494465U07
- 0494475U09
- 0494855G01
- 0495215U11
- 0495225U11
- 0495505G02
Distribution
Distributed nationwide across the United States.
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