Recall Z-1772-2013 ยท GCJ Laparoscope, General & Plastic Surgery
Ethicon Endo-Surgery Inc
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugat
| Date | Jul 19, 2013 (initiated Apr 8, 2013) |
| Status | Terminated |
| Reason | The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device. |
| Root cause | Packaging |
| Action | The firm, Ethicon Endo-Surgery, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 22, 2013 to all consignees/customers via overnight UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: EFFECTIVE IMMEDIATELY-DO NOT USE ANY OF THE FOLLOWING TWELVE (12) PRODUCT CODES within the noted Expiration Dates provide in the letter; examine your inventory immediately to determine if you have affected product on hand; remove the affected product; complete and return the Busines |
| Quantity | 327,648 instruments |
| Distribution | Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912492 | EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE ETHICON, Inc., Oct 21, 1991 |