Stryker Recalls StrykeFlow 2 System Due to Bioburden Testing Results
Stryker is recalling 60,753 units of the StrykeFlow 2 System because routine bioburden testing found levels higher than internal acceptable rates.
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 and involves a sterile medical device with bioburden levels exceeding internal rates, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 60,753 units of the StrykeFlow 2 System, a medical device labeled as sterile. The recall includes the Stryker Laparoscopic Suction Irrigator (Model 0250070500), the Disposable Strykeflow S/I Tip (Model 0250070505), and the Strykeflow 2 with Tip (Model 0250070520). Specific lot numbers are identified in the agency's recall record.
The recall was initiated because routine bioburden testing of certain lots revealed levels higher than the company's internal acceptable rates. The FDA has classified this as a Class II recall, indicating a situation that could temporarily cause adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected units were distributed domestically and internationally to Australia and Mexico. The source text does not specify the exact number of units distributed to each region or provide a list of specific facilities. Healthcare providers and facilities that have received these products should stop using them and contact Stryker Corporation for instructions on return or replacement.
The recalled product
- Product
- StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRI
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 60,753
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)
- a. Model 0250070500
- Product Code GCJ
- UDI 07613327061390
- Lot No. 17275FG2
- 17276FG2
- 17277FG2
- 17278FG2
- 17279FG2
- 17280FG2
- 17283FG2
- 17284FG2
- 17285FG2
- 17286FG2
- 17289FG2
- 17290FG2
- 17291FG2
- 17292FG2
- 17293FG2
- 17294FG2
- 17297FG2
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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