# FDA recall Z-1213-2019

> **COVIDIEN LLC** · Class II · device recall initiated 2019-03-13.

## Product

Procedure kits include devices from the affected lots distributed OUS only:  (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO	  (2)BOX KIT00680 KIT COLECISTECTOMIA-  (3)BOX KIT00681 KIT APENDICECTOMIA  (4)BOX KIT00897 KIT COLON  IZQUIERDO	  (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII	  (6)BOX PST01134 LAP CHOLE KIT ST JOHN S	  (7)KIT00599 LAPARO GENERICO X1	  (8)KIT00608 APENDICECTOMIA LAP X1	  (9)KIT2176CV BORNHOLM LAP INGUINAL HERNIA	  (10)KIT2951V CHOLECYSTECT BORNHOLM	  (11KIT2963 APPENDECTOMY KIT X1	(12)KITM025 M'LANDS MR NASSAR LAP CHOLEX1	    The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.                                                        1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO	  Lot Number: 0217118756  (2)BOX KIT00680 KIT COLECISTECTOMIA-  0217117865  0217118746  0217117863  0217117858  021711786

## Reason for recall

Sterilization method used was not consistent with the labeling and the approved sterilization method

## Distribution

Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.

## Key facts

- **Recall number:** Z-1213-2019
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-13
- **Report date:** 2019-05-01
- **Termination date:** 2020-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2019

## Citation

> AI Analytics. FDA recall Z-1213-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1213-2019. Source: US FDA. Licensed CC0.

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