Allergan Inc: 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.

Recall number

Z-2103-2015

Recalling firm

Allergan Inc

Product

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.

Status

Terminated

Initiated

2015-06-18

Posted

2015-07-18

Terminated

2015-12-16

Reason

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.

Root cause

Incorrect or no expiration date

Action

A recall letter will be sent on 6/18/15 to all customers who received the NATRELLE 133 and CUI series tissue expanders. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST.

Quantity

167 units total (114 units in US)

Distribution

US in the state of Canada

Lot, serial or model 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), 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).

510(k) numbers

["K862203"]

PMA numbers

not on file

Product code

LCJ

Firm FEI

2011068

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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