Reported Sep 18, 2019 · Ongoing
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander)…
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 (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile
- for the following style numbers
STYLE 133FV: 133FV-11133FV-12133FV-13133FV-14133FV-15133FV-16
- STYLE 133MV
133MV-11133MV-12133MV-13133MV-14133MV-15133MV-16
- STYLE 133LV
133LV-11133LV-12133LV-13133LV-14133LV-15133LV-16
- STYLE 133FX133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16
- STYLE 133MX
133MX-11133MX-12133MX-13133MX-14133MX-15133MX-16
- STYLE 133SX
133SX-11133SX-12133SX-13133SX-14133SX-15133SX-16
- STYLE 133SV133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; These products may have been sold under the McGhan, Inamed or NATRELLE brands
- 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 108886280039271088862800393410888628003941108886280039581088862800396510888628003972133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888628003941, 133FV-14 10888628003958, 133FV-15 10888628003965, 133FV-16 10888628003972 2 108886280041081088862800411510888628004122108886280041391088862800414610888628004153STYLE 133MV: 133MV-11 10888628004108, 133MV-12 10888628004115, 133MV-13 10888628004122, 133MV-14 10888628004139, 133MV-15 10888628004146, 133MV-16 10888628004153 3 108886280040471088862800405410888628004061108886280040781088862800408510888628004092STYLE 133LV: 133LV-11 10888628004047, 133LV-12 10888628004054, 133LV-13 10888628004061, 133LV-14 10888628004078, 133LV-15 10888628004085, 133LV-16 10888628004092 4 108886280039891088862800399610888628004009108886280040161088862800402310888628004030STYLE 133FX: 133FX-11 10888628003989, 133FX-12 10888628003996, 133FX-13 10888628004009, 133FX-14 10888628004016, 133FX-15 10888628004023, 133FX-16 10888628004030 5 108886280041601088862800417710888628004184108886280041911088862800420710888628004214STYLE 133MX: 133MX-11 10888628004160, 133MX-12 10888628004177, 133MX-13 10888628004184, 133MX-14 10888628004191, 133MX-15 10888628004207, 133MX-16 10888628004214 6 108886280038041088862800381110888628003828108886280038351088862800384210888628003859STYLE 133SX: 133SX-11 10888628003804, 133SX-12 10888628003811, 133SX-13 10888628003828, 133SX-14 10888628003835, 133SX-15 10888628003842, 133SX-16 10888628003859 7 108886280038661088862800387310888628003880108886280038971088862800390310888628003910STYLE 133SV: 133SV-11 10888628003866, 133SV-12 10888628003873, 133SV-13 10888628003880, 133SV-14 10888628003897, 133SV-15 10888628003903, 133SV-16 10888628003910 - 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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