Disposable StrykeFlow Tip recall: Sterility Concern
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to…
Why was Disposable StrykeFlow Tip recalled?
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.
- Product
- Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to…
- Recalling firm
- Stryker Endoscopy
- Quantity
- 496 boxes (6 tips per box)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)