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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Stradis Healthcare: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Agency Publication Date: January 11, 2023
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Affected Products

Product: Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466

Lot Numbers:
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Product: PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.

Assembly Number 477944, UDI-DI: M7524779441, Lot Numbers: 220974270, 220915145

Lot Numbers:
Numbers
Product: Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.

Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.

Lot Numbers:
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Product: Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;

Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161. a. Assembly Number 570-1159, UDI-DI: H65857011591, Lot Numbers: 221668682, 222501598, 222308841, 222521158, 222238329, 222276824, 221053079, 221872664; b. Assembly Number 570-1160, UDI-DI: H65857011601, Lot Numbers: 222521156, 222429019, 222428991, 220452660, 222439059, 222428995, 221055116, 222288188, 222501154, 222501155, 222521157, 220762521, 222509319, 222769004, 222639005, 220141429, 222508994; c. Assembly Number 570-1161, UDI-DI: H65857011611, Lot Numbers: 220692475, 222308200, 220251830, 220954105, 220962657, 222248185, 220250698, 222298349, 220251993, 222308198, 222298840, 222521804, 220963077, 220986550, 220141428; d. Assembly Number 570-1162, UDI-DI: H65857011621, Lot Numbers: 221196021, 220462656, 221056018, 221056532, 222308350, 221176016, 221054106, 221056019, 222308552, 222501299, 222501300, 222521301, 220973076, 220896020, 221026017, 213631427; e. Assembly Number 570-1164, UDI-DI: H65857011641, Lot Numbers: 222016037, 222358186, 222430336, 221946035, 222439014, 222430367, 222630366, 222902499, 220252640, 222496579, 221053074, 222350340, 222016033, 222016036, 222146031, 222358129, 222358550, 222496823, 222691515, 220462661, 222692162, 222016034, 222509320, 222692160, 221956029, 220452523, 222016032, 222499000; f. Assembly Number 570-1163, UDI-DI: H65857011631, Lot Numbers: 222290711, 221796024, 221796026, 221796027, 222497161, 222509729, 222510199, 221193075, 222458997, 221024107, 221796025, 222509511, 221796023, 221796022

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Product: PICC KIT, 10/CS, ACCESS MEDICAL LABEL

Assembly Number ACC-2550, UDI-DI: M752ACC25501, Lot Number: 220241506

Lot Numbers:
Number
Product: HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Assembly Number HCT10500, UDI-DI: M752HCT105002, Lot Number: 220602531

Lot Numbers:
Number
Product: HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Assembly Number HCT2050, UDI-DI: M752HCT20502, Lot Number: 220130152, 221677841

Lot Numbers:
Number
Product: HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972

Lot Numbers:
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Product: HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

Assembly Number HCT3916-1, UDI-DI: M752HCT391611, Lot Numbers: 222491279, 220113056, 222782510, 221306003, 220051819, 222149971, 222210292, 221245035, 221458554

Lot Numbers:
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Product: HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology

Assembly Number HCT8249CP-3, UDI-DI: M752HCT8249CP30, Lot Numbers: 222098152, 222551621, 221010141, 222309118, 222901807

Lot Numbers:
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Product: HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Assembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373

Lot Numbers:
Number
Product: Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group

Assembly Number MAG-3000, UDI-DI: M752MAG30001, Lot Numbers: 220883387, 221226000, 220960490, 220986568, 222074682, 222458932

Lot Numbers:
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Product: McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.

Assembly Number MC-3535PT, UDI-DI: M752MC3535PT1, Lot Numbers: 220673037, 222096813

Lot Numbers:
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Product: Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Assembly Number TCTR01, UDI-DI: M752TCTR011, Lot Numbers: 222014334

Lot Numbers:
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Product: Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Assembly Number TM.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, 222701385

Lot Numbers:
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Product: Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335

Lot Numbers:
Numbers
Product: Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.

Assembly Number TM8823-1, UDI-DI: M752TM882310, Lot Number: 220110674

Lot Numbers:
Number
Product: Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

Assembly Number VCP16515-1, UDI-DI: M765VCP1651511, Lot Number: 221925083

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91350
Status: Active
Manufacturer: Stradis Healthcare
Manufactured In: United States
Units Affected: 18 products (920 units; 300 units; 1,040 units; 21,755 units; 180 units; 644 units; 2,779 units; 112,675 units; 76,260 units; 1,176 units; 200 units; 2,500 units; 250 units; 80 units; 1,175 units; 275 units; 600 units; 200 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.