Z-1906-2024Class II
Trevo Trak 21 Microcatheter, Catalog: 90338
Stryker Corp. / initiated 2024-04-23 / Open, Classified / root cause: manufacturing process
Stryker Neurovascular began a recall of Trevo Trak 21 Microcatheter, Catalog: 90338 on . FDA classified it as Class II and gives the reason as "Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1906-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Stryker Corp.
- Product
- Trevo Trak 21 Microcatheter, Catalog: 90338
- Product code
- QJP Catheter, Percutaneous, Neurovasculature
- Reason for recall
- Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- On 4/23/24, recall notices were mailed to Supply Chain Management, Recall Coordinators, and Inventory Managers who were asked to do the following: 1) Cease further distribution or use of all affected devices. 2) Segregate the affected units in a secure location for return to the firm. 3) Circulate this Recall-Removal notice internally to all interested/affected parties. 4) Maintain awareness of this communication internally until all required actions have been completed within your facility. 5) Inform the firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so the firm can inform the recipients appropriately. 6) Inform the firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: [email protected]) 7) Complete and return the response form via email to [email protected]
- Quantity in commerce
- 899
- Distribution
- Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
- Product codes and lots
- Catalog: 90338, UDI-DI: 07613327313956, Lot: 119461, 119473, 119598, 120070, 120201, 120970, 140512, 136912, 136913, 136914, 136915
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1902-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1903-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1904-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1905-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1906-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1907-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1908-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1909-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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