Home / Recalls / Bioseal Corporation / Z-0085-2018

Z-0085-2018 Class II

Recalled by Bioseal Corporation — Placentia, CA

FDA device recall Z-0085-2018 was initiated by Bioseal Corporation on October 18, 2017 and is designated Class II. Reason for recall: Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. Affected quantity: 51635 units.

Recall Details

Product Type: Devices
Report Date: November 15, 2017
Initiation Date: October 18, 2017
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 51635 units

Product Description

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

Reason for Recall

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

Distribution Pattern

CA, IL, NC, VT

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

Other recalls by Bioseal Corporation

Z-1623-2021 Class II — Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: (March 23, 2021)
Z-1622-2021 Class II — Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: (March 23, 2021)
Z-1624-2021 Class II — Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: (March 23, 2021)
Z-2795-2020 Class II — Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Sing (August 15, 2019)