Z-0304-2011

Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601...

Name: Z-0304-2011 Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601...
Creator: Ethicon Endo-Surgery Inc
Published: 2010-09-27
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2010-09-27 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601... on 2010-09-27. The reason FDA records is "The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0304-2011
Status: Terminated
Initiated: 2010-09-27
Posted: 2010-11-02
Terminated: 2011-11-18
Recalling firm: Ethicon Endo-Surgery Inc
Product: Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601, 09270601, 20003156, ZHKBBB, ZJFBDK, ZJFBF6, ZJJBLR, ZJMBCD, ZJNBKW, ZKBBJV, ZKBBLK, ZKDB0B, ZKFBDG, ZKFBDJ, ZKGBBM, ZKGBDW, ZKHBCC, ZKHBDH, ZKKBDZ, ZKLBD9, ZKMBK1, ZKNBD7, ZLBBBJ, ZLCBC4, ZLCBGB, ZLDBBC, ZLFBGL, ZLGBC9 & ZLHBBJ.
Product code: LTI Implant, Intragastric For Morbid Obesity
Reason for recall: The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca
FDA root cause: Other
Action: Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.
Quantity in commerce: 2,520 pieces
Distribution: Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.
Product codes and lots: Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601, 09270601, 20003156, ZHKBBB, ZJFBDK, ZJFBF6, ZJJBLR, ZJMBCD, ZJNBKW, ZKBBJV, ZKBBLK, ZKDB0B, ZKFBDG, ZKFBDJ, ZKGBBM, ZKGBDW, ZKHBCC, ZKHBDH, ZKKBDZ, ZKLBD9, ZKMBK1, ZKNBD7, ZLBBBJ, ZLCBC4, ZLCBGB, ZLDBBC, ZLFBGL, ZLGBC9 & ZLHBBJ.

Product code LTI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)