Z-0135-2012

AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label...

Name: Z-0135-2012 AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label...
Creator: Sierra Scientific Instruments Inc
Published: 2011-10-12
License: https://open.fda.gov/license/

Sierra Scientific Instruments, Inc. / initiated 2011-10-12 / Terminated / root cause: manufacturing process

FDA source

Sierra Scientific Instruments Inc began a recall of AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual... on 2011-10-12. The reason FDA records is "The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0135-2012
Status: Terminated
Initiated: 2011-10-12
Posted: 2011-10-28
Terminated: 2012-08-30
Recalling firm: Sierra Scientific Instruments, Inc.
Product: AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Given Imaging sent an "Urgent Product Recall 1st Notice" letter with an attached Device Recall Confirmation Form (via Fed Ex with signature for tracking purposes) to all customers who purchased the AR ManoShield, part numbers MSS-3599. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to locate the affected product and removed from use immediately. The letter stated that if the affected product have been further distributed, forward this letter immediately to all customers who received the affected product. Customers were asked to complete and return the enclosed confirmation form as per the instructions. Customers with any questions were instructed to contact Karla Guerrero at (310) 641-8492 ext. 2138 or email at [email protected].
Quantity in commerce: 292 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.
Product codes and lots: F1112702UA, F1113101UA, F1113103UA, F1113104UA, F1113401UA, F1114201UA, F1114617UA, F1114618UA, F1114619UA, F1114620UA, F1114621UA, F1114623UA, F1114624UA, F1114625UA, F1114626UA, F1114627UA, F1114628UA, F1114629UA, F1115402UA, F1116306UA, F1117207UA, F1119201UA, F1119401UA, F1121304UA, F1123201UA, F1123405UA, F1123703UA, F1124202UA, F1124301UA, F1125105UA, F1125201UA, F1127303UA, F1128101UA, F1129701UA, F1130202UA, F1130304UA, F1128301UA, F1127103UA, F1127205UA,

Product code FFX

K031169Class IIMotility Visualization SystemSierra Scientific Instruments, Inc. / cleared 2003-12-12

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)