Reported Nov 15, 2017 · Completed
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture…
Bioseal Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bioseal Corporation · 167 W Orangethorpe Ave · Placentia, CA · 92870-6922
Is this the product you have?
- Custom surgical kits labeled as follows
(a) Suture Removal Set910-0002 (b) Instrument SetINST03/20 (c) Suture Removal SetSUT309/100 (d) Incision & Drainage TrayINC03/20 (e) Suture Removal SetSUT103/50 (f) General Purpose TrayGPT010/25 (g) General Purpose TrayGPT002/50
- Lot codes and dates
- Lot Numbers
(a) 910-0002: 400348400354400364400370400386 (b)
- INST03/20
400349400354400361400364400366400367400370400372400373400380400386400392400393400393400396400396400399400401400403400414400416400417400419400422400427 (c)
- SUT309/100
400346400354400361400364400366400370400373400396400397400403400407400408400413400430400354400361400370400373400407400408400413400370400396400408400430400346400354400361400362400364400370400397400373400396400397400403400407400408400413400427400430400354 (d)
- INC03/201137 (e)
- SUT103/50
400413400413400413400416400430400396400396400401400402400403400416 (f)
- GPT010/25
400348400351400355400364400369400376400385400389400395400402400414400422 (g)
- GPT002/50
400348400356400361400364400376400380400393400394400399400402400407400418400422400422400430
- Lot Numbers
- Amount recalled
- 51635 units
Where it was sold
Why it was recalled
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
This product could cause temporary or reversible health problems — stop using it.
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