Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 18, 2015 Allergan Implants & Prosthetics

What Should You Do?

Check if you have this product:
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), UM3161 (612983), UP7183 (614339), UP7173 (614339), QF7615 (620772), QG7571 (621426), 11237155 (1029108), NX9778 (559999), PN4372 (573203), PA0253 (561356), PW3861 (581836), PW8259 (582676), UN3074 (613518), PG1546 (567007), UW7921 (617765), 11200803 (1001347), 11201052 (1001668), 11206048 (1004514), 11206049 (1004514), 11206681 (1006447), 11250680 (1030868), 11250702 (1030871), 11514565 (1107468), 11250734 (1030876), 11263982 (1034109), 11269159 (1035181), 11269154 (1035181), 11284363 (1038784), 11307159 (1046470), 11348914 (1067365), 11346491 (1068038), 11367799 (1076435), 11406083 (1088212), 11406084 (1088212), 11406085 (1088212), 11424452 (1091673), 11637421 (1129216), 11718948 (1164435), 11729830 (1165720), 11739519 (1171269), 11759602 (1175538), 12477973 (1383846), 12477975 (1383846), 12495792 (1387445), 12567989 (1402594), 13098492 (1513910), 13098502 (1513910), 11247636 (1030431), 11254038 (1031312), 11368096 (1075819), 11458035 (1097974), 11458039 (1097974), 11458341 (1098680), 11478944 (1102774), 11347486 (1067367).
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Allergan Inc
Reason for Recall:: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 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.

Product Codes/Lot Numbers:

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), UM3161 (612983), UP7183 (614339), UP7173 (614339), QF7615 (620772), QG7571 (621426), 11237155 (1029108), NX9778 (559999), PN4372 (573203), PA0253 (561356), PW3861 (581836), PW8259 (582676), UN3074 (613518), PG1546 (567007), UW7921 (617765), 11200803 (1001347), 11201052 (1001668), 11206048 (1004514), 11206049 (1004514), 11206681 (1006447), 11250680 (1030868), 11250702 (1030871), 11514565 (1107468), 11250734 (1030876), 11263982 (1034109), 11269159 (1035181), 11269154 (1035181), 11284363 (1038784), 11307159 (1046470), 11348914 (1067365), 11346491 (1068038), 11367799 (1076435), 11406083 (1088212), 11406084 (1088212), 11406085 (1088212), 11424452 (1091673), 11637421 (1129216), 11718948 (1164435), 11729830 (1165720), 11739519 (1171269), 11759602 (1175538), 12477973 (1383846), 12477975 (1383846), 12495792 (1387445), 12567989 (1402594), 13098492 (1513910), 13098502 (1513910), 11247636 (1030431), 11254038 (1031312), 11368096 (1075819), 11458035 (1097974), 11458039 (1097974), 11458341 (1098680), 11478944 (1102774), 11347486 (1067367).