Z-0085-2018Class II

Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c)...

Name: Z-0085-2018 Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c)...
Creator: Bioseal Corporation
Published: 2017-10-18
License: https://open.fda.gov/license/

Bioseal / initiated 2017-10-18 / Completed / root cause: manufacturing process

FDA source

Bioseal Corporation began a recall of 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 &... on 2017-10-18. FDA classified it as Class II and gives the reason as "Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0085-2018
Classification: Class II
Status: Completed
Initiated: 2017-10-18
Posted: 2017-11-09
Recalling firm: Bioseal
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
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0085-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0085-2018	Class II	Completed	Voluntary: Firm initiated	2017-11-15	2017-11-09

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)