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Terumo Cardiovascular Procedure Kit Custom recallZ-2153-2010 · Terumo Cardiovascular Systems Corp · initiated Jun 8, 2010

Terminated All recalls posted in August 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Vent port may be occluded and prevent delivery of fluid

FDA root cause category: Equipment maintenance

What the company is doing

Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.

Recall details

Recall number
Z-2153-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 8, 2010
Posted by the FDA
Aug 2, 2010
Recalling firm
Terumo Cardiovascular Systems Corp
Quantity
6 packs
Product code
DTR
FDA submissions
K823451
Distribution
Distribution USA and Canada

Product description

Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01

Code information (models, lots, serial numbers)

Lots: MD22

Other devices under the same FDA submission

1 device cleared under K823451 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 56037).

Sources and updates

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