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Stryker Irrigator Reusable Tips recallZ-1235-2013 · Stryker Endoscopy · initiated Mar 27, 2013

Class II Terminated All recalls posted in May 2013

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 Stryker Endoscopy 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

The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.

FDA root cause category: Error in labeling

What the company is doing

Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Recall details

Recall number
Z-1235-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 27, 2013
Posted by the FDA
May 3, 2013
Recalling firm
Stryker Endoscopy
Quantity
147,921 - all sizes
Product code
GCX
FDA submissions
K954726
Distribution
Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.

Product description

Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.

Code information (models, lots, serial numbers)

Manufacturer Part Number: 250-070-489

Other devices under the same FDA submission

1 device cleared under K954726 — 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 64682).

Sources and updates

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