Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a potential loss of sterility in a medical device used in operative sites, which aligns with the rubric for Severe severity due to significant injury risk.
Plain-English summary
Stryker Endoscopy is recalling 496 boxes (6 tips per box) of Disposable StrykeFlow Tips. These sterile, prescription-only tips are used in the Stryker Suction Irrigation system to provide a clean operative site during endoscopic procedures.
An internal review determined that six lots of the tips were shipped with a potentially deformed blister pouch. This defect could impact the sterility of the product, posing a risk to patients.
The affected lots are 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, and 14016FG2 (P/N 0250070505). The products were distributed nationwide in the United States and internationally to Australia, Canada, France, Greece, the Netherlands, the United Kingdom, and South Korea. Healthcare providers should stop using these specific lots and contact Stryker Endoscopy for instructions on return or replacement.
The recalled product
- Product
- Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
- Manufacturer
- Stryker Endoscopy
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 (7)
- P/N 0250070505
- Lot numbers: 14021FG2
- 13337FG2
- 13343FG2
- 13347FG2
- 14007FG2
- 14016FG2.
Distribution
Distributed nationwide across the United States.
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