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Recall Observatory FDA recall evidence

Device 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.

Z-1050-2015

June 11, 2014

Class II

Product summary

Firm
Hospira Inc.
Event
Event 68672
Status
Terminated
Classification
Class II
Quantity
102 infusors
Official record key
device-enforcement:Z-1050-2015

Official wording

Reason: 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.

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

Distribution pattern: US Distribution to New York.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.