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U.S. Department of Health and Human Services

Class 2 Device Recall Custom surgical kits

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  Class 2 Device Recall Custom surgical kits see related information
Date Initiated by Firm October 18, 2017
Create Date November 09, 2017
Recall Status1 Completed
Recall Number Z-0085-2018
Recall Event ID 78375
Product Classification Kit, surgical instrument, disposable - Product Code KDD
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
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
Recalling Firm/
Manufacturer		 Bioseal Corporation
167 W Orangethorpe Ave
Placentia CA 92870-6922
For Additional Information Contact
714-528-4695
Manufacturer Reason
for Recall		 Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm initiated the recall by letter on 10/18/2017. The letter requested the consignee discontinue use of the product and notify the recalling firm with the quantities on hand for return. Those consignee who further distributed the product were directed to notify their customers and have the affected products returned to them for return to Bioseal.
Quantity in Commerce 51635 units
Distribution CA, IL, NC, VT
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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