Reported Sep 18, 2019 · Ongoing
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle…
Allergan PLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G
- Needle Infusion Set STYLE 133FV-T
133FV-11-T133FV-12-T133FV-13-T133FV-14-T133FV-15-T133FV-16-T
- STYLE 133MV-T
133MV-11-T133MV-12-T133MV-13-T133MV-14-T133MV-15-T133MV-16-T
- STYLE 133LV-T
133LV-11-T133LV-12-T133LV-13-T133LV-14-T133LV-15-T133LV-16-T
- STYLE 133SV-T
133SV-11-T133SV-12-T133SV-13-T133SV-14-T133SV-15-T133SV-16-T
- STYLE 133FX-T
133FX-11-T133FX-12-T133FX-13-T133FX-14-T133FX-15-T133FX-16-T
- STYLE 133MX-T
133MX-11-T133MX-12-T133MX-13-T133MX-14-T133MX-15-T133MX-16-T
- STYLE 133SX-T
133SX-11-T133SX-12-T133SX-13-T133SX-14-T133SX-15-T133SX-16-T
- Product Usageintended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 108886280042211088862800423810888628004245108886280042521088862800426910888628004276133FV-11-T 10888628004221, 133FV-12-T 10888628004238, 133FV-13-T 10888628004245, 133FV-14-T 10888628004252, 133FV-15-T 10888628004269, 133FV-16-T 10888628004276 2 108886280044051088862800441210888628004429108886280044361088862800444310888628004450STYLE 133MV-T: 133MV-11-T 10888628004405, 133MV-12-T 10888628004412, 133MV-13-T 10888628004429, 133MV-14-T 10888628004436, 133MV-15-T 10888628004443, 133MV-16-T 10888628004450 3 108886280043441088862800435110888628004368108886280043751088862800438210888628004399STYLE 133LV-T: 133LV-11-T 10888628004344, 133LV-12-T 10888628004351, 133LV-13-T 10888628004368, 133LV-14-T 10888628004375, 133LV-15-T 10888628004382, 133LV-16-T 10888628004399 4 108886280042831088862800429010888628004306108886280043131088862800432010888628004337STYLE 133FX-T: 133FX-11-T 10888628004283, 133FX-12-T 10888628004290, 133FX-13-T 10888628004306, 133FX-14-T 10888628004313, 133FX-15-T 10888628004320, 133FX-16-T 10888628004337 5 108886280044671088862800447410888628004481108886280044981088862800450410888628004511STYLE 133MX-T: 133MX-11-T 10888628004467, 133MX-12-T 10888628004474, 133MX-13-T 10888628004481, 133MX-14-T 10888628004498, 133MX-15-T 10888628004504, 133MX-16-T 10888628004511 6 108886280045801088862800459710888628004603108886280046101088862800462710888628004634STYLE 133SX-T: 133SX-11-T 10888628004580, 133SX-12-T 10888628004597, 133SX-13-T 10888628004603, 133SX-14-T 10888628004610, 133SX-15-T 10888628004627, 133SX-16-T 10888628004634 7 108886280045281088862800453510888628004542108886280045591088862800456610888628004573STYLE 133SV-T: 133SV-11-T 10888628004528, 133SV-12-T 10888628004535, 133SV-13-T 10888628004542, 133SV-14-T 10888628004559, 133SV-15-T 10888628004566 133SV-16-T 10888628004573 - Amount recalled
- 4,026,287 Breast Implants and Tissue Expanders Combined in total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Using this product could cause serious injury, illness or death — stop using it now.
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