Recalls / —

—#93290

Product

Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560

FDA product code

FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K983220

Affected lot / code info

PSTR010710-1, PSTR081109-1, PSTR081109-2, PSTR081209-1, PSTR081309-2,  PSTR082109-1, PSTR082709-1, PSTR082809-1, PSTR090809-1, PSTR091809-1,  PSTR091809-2, PSTR092409-1, PSTR100309-1, PSTR100909-1, PSTR110609-1,  PSTRI20709-2, PSTR121809-1, PSTR122209-1, STR021009-8R, STR022709-1R,  STR022709-2R, and STR041709-4R

Why it was recalled

The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.

Root cause (FDA determination)

Device Design

Action the firm took

On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.

Recalling firm

Firm

Stryker Endoscopy

Address

5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern

Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).

Timeline

Recall initiated

2010-05-11

Posted by FDA

2011-02-01

Terminated

2011-02-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #93290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.