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Completed

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

FDA Recall Z-0085-2018 · Posted None

Recalling FirmBioseal Corporation
Recall StatusCompleted
Product CodeKDD
Date Initiated2017-10-18
Product Quantity51635 units

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

CA, IL, NC, VT

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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