Stryker High Flow II Tube Set Recalled for Leaking and Detachment
Stryker is recalling High Flow II Tube Sets because they consistently leak and detach from the cassette. The product is a medical device accessory distributed nationwide and internationally.
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 is classified as FDA Class II. The hazard involves a functional defect (leaking/detachment) in a medical device that poses a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling the Stryker High Flow II Tube Set, REF 0620-040-660. This product is a disposable, sterile, prescription-only accessory used with the PNEUMO SURE High Flow Insufflator. The recall involves 32,537 boxes of the tube sets.
The recall was initiated because the heated tube sets were consistently leaking and detaching from the cassette. This defect could compromise the function of the insufflator system during medical procedures.
Distribution was nationwide to medical facilities, including government and military distribution. Foreign distribution included Argentina, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Saudi Arabia, UAE, and Uruguay, among other regions. Consumers and medical facilities should stop using the affected units and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 32,537
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)
- UDI - 07613327055634 Lot numbers: 18G0269
- 18H0353
- 18K0379
- 56004320
- 56004325
- 56004329
- 56004356
- 56004366
- 56004373
- 56004384
- 56004387
- 56004426
- 56004432
- 56004441
- 56004443
- 56004451
- 56004459
- 56004461
- 56004487
- 56004494
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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