Home / Recalls / Stradis Healthcare / Z-0934-2023

Z-0934-2023 Class II Ongoing

Recalled by Stradis Healthcare — Waukegan, IL

FDA device recall Z-0934-2023 was initiated by Stradis Healthcare on December 15, 2022 and is designated Class II. Reason for recall: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. The recall status is ongoing. Affected quantity: 21,755 units.

Recall Details

Product Type
Devices
Report Date
January 18, 2023
Initiation Date
December 15, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,755 units

Product Description

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;

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Code Information

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

Other recalls by Stradis Healthcare

  • Z-0939-2023 Class II — HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health (December 15, 2022)
  • Z-0948-2023 Class II — Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital (December 15, 2022)
  • Z-0940-2023 Class II — HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technol (December 15, 2022)
  • Z-0941-2023 Class II — HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Tech (December 15, 2022)
  • Z-0931-2023 Class II — Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and cathe (December 15, 2022)
  • Z-0945-2023 Class II — Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags pe (December 15, 2022)
  • Z-0933-2023 Class II — Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. (December 15, 2022)
  • Z-0936-2023 Class II — HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER (December 15, 2022)
  • Z-0932-2023 Class II — PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptia (December 15, 2022)
  • Z-0935-2023 Class II — PICC KIT, 10/CS, ACCESS MEDICAL LABEL (December 15, 2022)

FDA data resources