Reported Jul 29, 2015 · Terminated
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for…
Allergan Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Inc · 2525 Dupont Dr · Irvine, CA · 92612-1531
Is this the product you have?
- Natrelle CUI Series Tissue Expanders
- Product UsageNatrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port
- Lot codes and dates
Serial No. (Lot No.) VE7507 (5F075-OEM)VE9273 (6H009-OEM)VF4561 (09H024-OEM)VF5340 (10A115-OEM)VE9272 (6H009-OEM)VF3627 (09E231-OEM)VE9117 (6F158-OEM)VF1201 (7K195-OEM)VF5396 (10A182-OEM)VF5341 (10A115-OEM)VF4923 (09J052-OEM)VF1420 (7L085-OEM)VF1327(7L043-OEM)VE7508 (5F075-OEM)VF1427 (7L085-OEM)VE9274 (6H009-OEM)
- Amount recalled
- 23 units total (16 units in US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
This product could cause temporary or reversible health problems — stop using it.
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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