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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Plum A Infuser

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  Class 2 Device Recall Hospira Plum A Infuser see related information
Date Initiated by Firm June 11, 2014
Date Posted February 04, 2015
Recall Status1 Terminated 3 on November 28, 2016
Recall Number Z-1050-2015
Recall Event ID 68672
510(K)Number K042081  
Product Classification Pump, infusion - Product Code FRN
Product Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. The pole clamp assembly is used to provide a mechanism to tighten and loosen the grip of the pole clamp to remove the infuser from the IV pole.
Code Information List Number: 20792-04-25;   Serial Numbers: 17737372 ; 17737375 ; 17737377 ; 17737378 ; 17737383 ; 17737385 ; 17737390 ; 17737394 ; 17737395 ; 17737396 ; 17737397 ; 17737398 ; 17737399 ; 17737400 ; 17737402 ; 17737405 ; 17737408 ; 17737409 ; 17737414 ; 17737416 ; 17737419 ; 17737420 ; 17737421 ; 17737422 ; 17737424 ; 17737425 ; 17737426 ; 17737429 ; 17737430 ; 17737431 ; 17737432 ; 17737433 ; 17737435 ; 17737438 ; 17737440 ; 17737442 ; 17737443 ; 17737444 ; 17737445 ; 17737446 ; 17737447 ; 17737448 ; 17737449 ; 17737450 ; 17737451 ; 17737452 ; 17737454 ; 17737456 ; 17737458 ; 17737459 ; 17737460 ; 17737462 ; 17737463 ; 17737464 ; 17737467 ; 17737470 ; 17737475 ; 17737476 ; 17737478 ; 17737479 ; 17737480 ; 17737483 ; 17737485 ; 17737486 ; 17737489 ; 17737490 ; 17737492 ; 17737498 ; 17737500 ; 17737501 ; 17737502 ; 17737506 ; 17737507 ; 17737508 ; 17737511 ; 17737514 ; 17737516 ; 17737518 ; 17737520 ; 17737521 ; 17737522 ; 17737524 ; 17737525 ; 17737526 ; 17737531 ; 17737533 ; 17737535 ; 17737539 ; 17737542 ; 17737545 ; 17737546 ; 17737550 ; 17737551 ; 17737556 ; 17737557 ; 17737558 ; 17737559 ; 17737560 ; 17737562 ; 17737564 ; 17737569 ; 17737575
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Hospira Global Complaint Management
800-441-4100
Manufacturer Reason
for Recall		 Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole.
FDA Determined
Cause 2		 Vendor change control
Action Hospira contacted the the sole customer on June 11, 2014, to inform them of the issue of the potential impact to their Plum A+ infusers list 20792-04-25. Hospira requested that the customer to allow Hospira Field Service Representatives to inspect and replace the impact pole clamp assemblies. On June 12, 2013 Geneva Hospital approved Hospira's request to the inspection and replacement of the impacted pole clamp assemblies. On June 16, 2013 Hospira's Field Service personnel performed the on-site, visual inspection of the pole clamp assemblies and confirmed 15 units were cracked. Hospira determined to replace all 102 pole clamp assemblies that were received by Geneva Hospital. For further questions please call (800) 441- 4100.
Quantity in Commerce 102 infusors
Distribution US Distribution to New York.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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