Reported Dec 25, 2019 · Terminated
Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style…
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 Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI
55 of 55 products
| Model / number | Product as published |
|---|---|
10888628000513 | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low |
10888628000520 | NATRELLE Style 68LP-150 Saline Round Low |
10888628000537 | NATRELLE Style 68LP-175 Saline Round Low |
10888628000544 | NATRELLE Style 68LP-200 Saline Round Low |
10888628000551 | NATRELLE Style 68LP-225 Saline Round Low |
10888628000568 | NATRELLE Style 68LP-250 Saline Round Low |
10888628000575 | NATRELLE Style 68LP-275 Saline Round Low |
10888628000582 | NATRELLE Style 68LP-300 Saline Round Low |
10888628000599 | NATRELLE Style 68LP-325 Saline Round Low |
10888628000605 | NATRELLE Style 68LP-350 Saline Round Low |
10888628000612 | NATRELLE Style 68LP-400 Saline Round Low |
10888628000629 | NATRELLE Style 68LP-420 Saline Round Low |
10888628000636 | NATRELLE Style 68LP-440 Saline Round Low |
10888628000643 | NATRELLE Style 68LP-480 Saline Round Low |
10888628000650 | NATRELLE Style 68LP-525 Saline Round Low |
10888628000667 | NATRELLE Style 68LP-550 Saline Round Low |
10888628000674 | NATRELLE Style 68LP-600 Saline Round Low |
10888628000681 | NATRELLE Style 68LP-640 Saline Round Low |
10888628000698 | NATRELLE Style 68LP-680 Saline Round Low |
10888628000353 | Style 68 HP/UDI: NATRELLE Style 68HP-160 Saline Round High |
- Lot codes and dates
- MFG BATCH numbers
3,620 of 3,620 codes
280509628367862884422288999928717402878486279726428844263036126305907030764513124452313147931398823154328315749331732203176664321309732287432776706288442729090552921210300801730227333035530305946330810933096446312477331277743142976315456631570863157779316081731640793167339317366431769183182507320386732082833211090322612528308602868178288442829177762958518296180230160933019001303626130592683076606309171330940373124627
- MFG BATCH numbers
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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.