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

Z-0934-2023 Class II Ongoing

Recalled by Stradis Healthcare — Waukegan, IL

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

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