medical MODERATE Updated 2022-10-05

CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) f

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Recalled Product

Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.

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Hazard / Issue

There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.

Issued by

FDA

Affected States: AL, AZ, CA, CT, DE, FL, GA, HI, IL, KS, MA, MI, MN, MO, NJ, NY, OH, OR, SC, TX, VA, VT, WA, WI, WV
Lot/Code Info: Lot Numbers 05593V291121 18-1192 1812-68 18-1268 G000575 G003811 G003893 G004517 G004874 G005109 G005476 G005723 E160415 Expiration date range: 27 Jun 2022 to 07 Dec 2024

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Humidifier bottle and syringe →
View official government recall