HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag

FDA device recall Z-1673-2012 · posted 2012-05-25 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMONIC Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04). The procedure is interrupted when

Action taken

Ethicon Endo-Surgery Inc sent an URGENT: Product Correction Notification letter dated March 2012 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Labels were enclosed that are used to identify the recalled product. Customers were instructed to fill out the Business Reply Form and fax it to Stericycle at 1-888-912-7091 within three business days for a credit. For questions regarding this recall call 513-337-3419.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LFL

Quantity affected

1896 instruments

Distribution

Worldwide Distribution-USA including: AK,AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NCND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, and WY. and the

Date initiated

2012-03-16

Date posted

2012-05-25

Date terminated

2013-03-05

Location

Cincinnati, OH

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