Reported Jan 27, 2016 · Terminated
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use…
Abeon Medical 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: Abeon Medical Corporation · 8000 Katherine Blvd · Brecksville, OH · 44141-4202
Is this the product you have?
- TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
- Lot codes and dates
112 of 112 products
Products covered by this recall Model / number Product as published — Lot # 14112171 Exp Date 2017/11 — Lot # 14112177 Exp Date 2017/11 — Lot # 14120576 Exp Date 2017/05 — Lot # 14120579 Exp Date 2017/11 — Lot # 14121661 Exp Date 2017/12 — Lot # 14121862 Exp Date 2017/12 — Lot # 14121863 Exp Date 2017/12 — Lot # 15010199 Exp Date 2017/12 — Lot # 15010200 Exp Date 2017/12 — Lot # 15011528 Exp Date 2018/01 — Lot # 15011529 Exp Date 2018/01 — Lot # 15011530 Exp Date 2018/01 — Lot # 15011531 Exp Date 2018/01 — Lot # 15012638 Exp Date 2017/12 — Lot # 15012640 Exp Date 2017/11 — Lot # 15013724 Exp Date 2017/11 — Lot # 15013788 Exp Date 2018/01 — Lot # 15013789 Exp Date 2018/01 — Lot # 15013790 Exp Date 2018/01 — Lot # 15013791 Exp Date 2018/01 - Amount recalled
- 2,570 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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