FDA Device recall Z-2140-2016
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum,…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum,… by Hospira, citing hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2140-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-08 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | US |
Product
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.
Reason
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
Identifiers
| code_info | List No. 12384; Serial Numbers: 12920041 ; 12920048 ; 12920052 ; 12920056 ; 12920066 ; 12920069 ; 12920079 ; 129…List No. 12384; Serial Numbers: 12920041 ; 12920048 ; 12920052 ; 12920056 ; 12920066 ; 12920069 ; 12920079 ; 12920082 ; 12920101 ; 12920102 ; 12920104 ; 12920105 ; 12920106 ; 12920107 ; 12920117 ; 12920121 ; 12920122 ; 12920152 ; 12920158 ; 12920159 ; 12920160 ; 12920174 ; 12920246 ; 12920248 ; 12920251 ; 12920252 ; 12920255 ; 12920257 ; 12920264 ; 12920265 ; 12920268 ; 12920270 ; 12920275 ; 12920276 ; 12920277 ; 12920278 ; 12920282 ; 12920287 ; 12920289 ; 12920291 ; 12920294 ; 12920304 ; 12920305 ; 12920311 ; 12920312 ; 12920320 ; 12920328 ; 12920330 ; 12920332 ; 12920340 ; 12920343 ; 12920346 ; 12920347 ; 12920352 ; 12920353 ; 12920357 ; 12920358 ; 12920359 ; 12920360 ; 12920362 ; 12920364 ; 12920369 ; 12920371 ; 12920372 ; 12920377 ; 12920381 ; 12920382 ; 12920383 ; 12920384 ; 12920387 ; 12920388 ; 12920390 ; 12920392 ; 12920398 ; 12920401 ; 12920403 ; 12920404 ; 12920405 ; 12920410 ; 12920412 ; 12920413 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2140-2016%22
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