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Recall Observatory FDA recall evidence

Device product

Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

Z-0085-2018

October 18, 2017

Class II

Product summary

Firm
Bioseal Corporation
Event
Event 78375
Status
Completed
Classification
Class II
Quantity
51635 units
Official record key
device-enforcement:Z-0085-2018

Official wording

Reason: Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

Code information: Lot Numbers: (a) 910-0002: 400348, 400354, 400364, 400370, 400386 (b) INST03/20: 400349, 400354, 400361, 400364, 400366, 400367, 400370, 400372, 400373, 400380, 400386, 400392, 400393, 400393, 400396, 400396, 400399, 400401, 400403, 400414, 400416, 400417, 400419, 400422, 400427 (c) SUT309/100: 400346, 400354, 400361, 400364, 400366, 400370, 400373, 400396, 400397, 400403, 400407, 400408, 400413, 400430, 400354, 400361, 400370, 400373, 400407, 400408, 400413, 400370, 400396, 400408, 400430, 400346, 400354, 400361, 400362, 400364, 400370, 400397, 400373, 400396, 400397, 400403, 400407, 400408, 400413, 400427, 400430, 400354 (d) INC03/20: 1137 (e) SUT103/50: 400413, 400413, 400413, 400416, 400430, 400396, 400396, 400401, 400402, 400403, 400416 (f) GPT010/25: 400348, 400351, 400355, 400364, 400369, 400376, 400385, 400389, 400395, 400402, 400414, 400422 (g) GPT002/50: 400348, 400356, 400361, 400364, 400376, 400380, 400393, 400394, 400399, 400402, 400407, 400418, 400422, 400422, 400430

Distribution pattern: CA, IL, NC, VT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

Field note

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