FDAJuly 24, 2019device
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-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 13...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
allergan plcallergan
UPCs
108886280042211088862800423810888628004245108886280042521088862800426910888628004276108886280044051088862800441210888628004429108886280044361088862800444310888628004450
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack ...2025-11-07
- FDABrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous ...2025-11-07
- FDABrand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pa...2025-11-07
- FDABrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pa...2025-11-07
- FDABrand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack ...2025-11-07
- FDABrand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack ...2025-11-07
- FDAKeller Funnel 2, REF: HA-001, STERILEEO, Rx Only,2024-03-14
- FDAChildren's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-262021-10-26
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