Z-1336-2019Class II

Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on...

Name: Z-1336-2019 Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on...
Creator: Shippert Medical Technologies
Published: 2018-02-02
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2018-02-02 / Completed / root cause: packaging

FDA source

Shippert Medical Technologies began a recall of Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies... on 2018-02-02. FDA classified it as Class II and gives the reason as "The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1336-2019
Classification: Class II
Status: Completed
Initiated: 2018-02-02
Posted: 2019-05-15
Recalling firm: Summit Medical, LLC
Product: Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Product code: MUU System, Suction, Lipoplasty
Reason for recall: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Letters dated 1/9/2018 were issued beginning 2/2/2018 via registered mail and Fed Ex explaining the reason for recall, risk to health, description of how to recognize the device failed, and actions to be taken.
Quantity in commerce: 6,553 units were distributed for all catalog numbers
Distribution: Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,
Product codes and lots: 61656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1336-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1330-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1331-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1332-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1333-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1334-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1335-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1336-2019	Class II	Completed	Voluntary: Firm initiated	2019-05-22	2019-05-15

Product code MUU

K092482Class IITissu Trans Filtron, Models 3-Tt-Filtron 2000-500Shippert Medical Technologies Corp. / cleared 2009-12-04

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)