Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc. Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for PICC KIT, 10/CS, ACCESS MEDICAL LABEL Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distrib... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology. Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology. Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcar... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Dis... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactu... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. ... Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc. Dec 15, 2022 FDA device enforcement
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Official source for Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc. May 10, 2022 FDA device enforcement
Potential for incomplete seals.
Class II Reported ongoing
Distribution: Pennsylvania
Official source for VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS Apr 22, 2022 FDA device enforcement
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Class II Reported terminated
Distribution: US Distribution to NC.
Official source for Surgical Suture Kit