FDA Device recall Z-2103-2015
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation…
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation… by Allergan, citing allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2103-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-18 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Allergan |
| Distribution | n/a |
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.
Reason
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Identifiers
| code_info | Serial No. (Lot No.) 11250691 (1030868), 11514564 (1107468), 11560447 (1120606), 14410441 (1745182), 14460177 (1752996)…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2103-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.