FDA Device recall Z-1517-2015

The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed l…

FDA Device
Class II
terminated
Published 2015-04-29

On 2015-04-29 the FDA classified a Class II recall of The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed l… by Hospira, citing the infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1517-2015
Classification	Class II
Status	terminated
Initiated	2013-02-27
Published	2015-04-29
Last updated	2026-09-13 11:53 UTC
Company	Hospira
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.

Reason

The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

Identifiers

code_info	List 12384: Serial Numbers: 12920041 , 12920048 , 12920052 , 12920056 , 12920066 , 12920069 , 12920079 , 1292008… List 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 ,

code_info

List 12384: Serial Numbers: 12920041 , 12920048 , 12920052 , 12920056 , 12920066 , 12920069 , 12920079 , 1292008…

List 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 ,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1517-2015%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.