Reported Jan 27, 2016 · Terminated
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a…
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 Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
- Lot codes and dates
50 of 50 products
Products covered by this recall Model / number Product as published — Lot # 14121931 Exp Date 2017/12 — Lot # 14121932 Exp Date 2017/12 — Lot # 15010126 Exp Date 2018/01 — Lot # 15013122 Exp Date 2018/01 — Lot # 15013123 Exp Date 2018/01 — Lot # 15024395 Exp Date 2018/02 — Lot # 15024396 Exp Date 2018/02 — Lot # 15031873 Exp Date 2018/03 — Lot # 15032061 Exp Date 2017/12 — Lot # 15034503 Exp Date 2017/10 — Lot # 15040520 Exp Date 2018/02 — Lot # 15041108 Exp Date 2017/12 — Lot # 15044716 Exp Date 2018/04 — Lot # 15050175 Exp Date 2018/01 — Lot # 15051473 Exp Date 2018/05 — Lot # 15051950 Exp Date 2018/04 — Lot # 15054517 Exp Date 2018/05 — Lot # 15062732 Exp Date 2018/04 — Lot # 15070461 Exp Date 2018/02 — Lot # 15070515 Exp Date 2018/02 - Amount recalled
- 1,035 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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