Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved di

FDA device recall Z-1772-2013 · posted 2013-07-19 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

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.

Action taken

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 Business Reply Form (BRF) and fax to: 1-888-912-7089 or email to: ees3118@stericycle.com within 3 business days, even if you do not have affected product; return affected product with a photocopy of the completed BRF; and share this information with all of the appropriate staff at your facility. If you need additional shipping labels or a communications package, contact the Stericycle's support center at 1-888-943-4896 and reference Event 3118. "Returned ENDOPATH Probe Plus II Shafts will be replaced with corrected ENDOPATH Probe Plus II Shafts once supply becomes available. If replacement product is not available and/or has been discontinued, a credit will be issue." If you need clinical or product support, please contact your local representative or call our Customer Support Center, 1-877-ETHICON (877-384-4266).

Root cause

Packaging

Status

Terminated

Product code

GCJ

Quantity affected

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,

Date initiated

2013-04-08

Date posted

2013-07-19

Date terminated

2013-12-24

Location

Cincinnati, OH

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