Reported Jul 29, 2015 · Terminated
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary…
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 133
- Series Tissue Expanders Product UsageNatrelle 133 Series Tissue Expander is intended 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
114 of 114 codes
Serial No. (Lot No.) 11250691 (1030868)11514564 (1107468)11560447 (1120606)14410441 (1745182)14460177 (1752996)14651643 (1782042)14645258 (1781272)14418851 (1747035)14663483 (1784601)14768174 (1800575)11650852 (1146235)11759596 (1175538)11783801 (1181003)PX1195 (583159)VB9805 (1-116051)PG1537 (567007)PH8804 (569489)PK3108 (570078)PK3369 (570134)PK3381 (570134)PK6626 (570491)PK8403 (570651)PL0978 (570658)PL8893 (571285)PM0276 (571744)PM0279 (571744)PM1034 (571785)PM1035 (571785)PR2461 (575450)PU9968 (579552)PW3583 (581746)PY7600 (585517)QA8130 (592961)QD5894 (619680)NX6700 (559633)QE7679 (620372)11267520 (1034755)QF7608 (620772)QF7606 (620772)QF9587 (621060)QJ6913 (622768)QP0282 (624977)NW1978 (558962)UM5622 (612529A)PK3255 (569968)PK3423 (570136)PK7369 (570539)PP0932 (574053)PR2462 (575450)QF9588 (621060)11372224 (1076904)11397846 (1080914)PT8307 (577871)PT8312 (577871)PU3940 (578909)PV9233 (581160)PV9228 (581160)PW8262 (582676)PW8276 (582676)PW3563 (581746)
- Amount recalled
- 167 units total (114 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 product shipped was beyond the 47 month 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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