Stradis Healthcare Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Brand
Stradis Healthcare
Lot Codes / Batch Numbers
Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335
Products Sold
Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335
Stradis Healthcare is recalling Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Ma due to Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Recommended Action
Per FDA guidance
Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026