Reported Dec 25, 2019 · Terminated
NATRELLE Resterilizable Sizers for the styles and sizes
Allergan PLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Allergan PLC · 2525 Dupont Dr · Irvine, CA · 92612-1531
Is this the product you have?
NATRELLE Resterilizable Sizers for the styles and sizes
59 of 59 products
| Model / number | Product as published |
|---|---|
10888628005587 | NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty 10-360 Rstrl Sizer Gel Mod |
10888628005594 | NATRELLE Sty 10-390 Rstrl Sizer Gel Mod |
10888628005600 | NATRELLE Sty 10-420 Rstrl Sizer Gel Mod |
10888628005617 | NATRELLE Sty 10-450 Rstrl Sizer Gel Mod |
10888628005624 | NATRELLE Sty 10-480 Rstrl Sizer Gel Mod |
10888628005631 | NATRELLE Sty 10-510 Rstrl Sizer Gel Mod |
10888628005679 | NATRELLE Sty 10-700 Rstrl Sizer Gel Mod |
10888628005686 | NATRELLE Sty 10-750 Rstrl Sizer Gel Mod |
10888628005693 | NATRELLE Sty 10-800 Rstrl Sizer Gel Mod |
10888628005778 | Style 15/UDI: NATRELLE Sty 15-304 Rstrl Sizer Gel Mid |
10888628005785 | NATRELLE Sty 15-339 Rstrl Sizer Gel Mid |
10888628005792 | NATRELLE Sty 15-371 Rstrl Sizer Gel Mid |
10888628005808 | NATRELLE Sty 15-397 Rstrl Sizer Gel Mid |
10888628005815 | NATRELLE Sty 15-421 Rstrl Sizer Gel Mid |
10888628005822 | NATRELLE Sty 15-457 Rstrl Sizer Gel Mid |
10888628005839 | NATRELLE Sty 15-492 Rstrl Sizer Gel Mid |
10888628005846 | NATRELLE Sty 15-533 Rstrl Sizer Gel Mid |
10888628005853 | NATRELLE Sty 15-575 Rstrl Sizer Gel Mid |
10888628005860 | NATRELLE Sty 15-616 Rstrl Sizer Gel Mid |
10888628006003 | Style 20/UDI: NATRELLE Sty 20-350 Rstrl Sizer Gel High |
- Lot codes and dates
- MFG BATCHES
3,621 of 3,621 codes
280509628367862884422288999928717402878486279726428844263036126305907030764513124452313147931398823154328315749331732203176664321309732287432776706288442729090552921210300801730227333035530305946330810933096446312477331277743142976315456631570863157779316081731640793167339317366431769183182507320386732082833211090322612528308602868178288442829177762958518296180230160933019001303626130592683076606309171330940373124627
- MFG BATCHES
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
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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