A zipser clamp is an instrument used to compress reduce recall
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss…
Why was A zipser clamp is an instrument used to compress reduce recalled?
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Boss Instruments Item Number: 46-5195; Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4"; Surgical Direct Item Number: SD16450.100; Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4"; Surgipro Item Number: SPGU-4570; Lot Number: 060810.
- Product
- A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 81 clamps
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)