Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Reported: June 12, 2019 Initiated: March 7, 2019 #Z-1726-2019
Product Description
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Reason for Recall
The heated tube sets were consistently leaking and detaching from the cassette.
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 32,537 boxes
- Distribution
- Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.. Recalled by Stryker Corporation. Units affected: 32,537 boxes.
Why was this product recalled? ▼
The heated tube sets were consistently leaking and detaching from the cassette.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1726-2019.
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