Z-2261-2016Class II

Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000...

Name: Z-2261-2016 Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000...
Creator: The Metrix Company
Published: 2016-06-23
License: https://open.fda.gov/license/

The Metrix Company / initiated 2016-06-23 / Terminated / root cause: design

FDA source

The Metrix Company began a recall of Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL on 2016-06-23. FDA classified it as Class II and gives the reason as "An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2261-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Posted: 2016-07-22
Terminated: 2023-04-11
Recalling firm: The Metrix Company
Product: Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Root cause tag: design
FDA root cause: Device Design
Action: On 6/23/2016, the recalling firm sent written recall notices to their distributors and end users notifying them of the recall. Customers and consignees were instructed to not use the devices, locate and quarantine all affected devices, and to complete the response form.
Quantity in commerce: 18,366 cases
Distribution: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
Product codes and lots: All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58740, 58741, 58742, 58749, 58750, 58753, 58754

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2257-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2258-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2259-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2260-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2261-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2262-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2263-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22
Z-2264-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22

Product code NEP

K843523Class IIEmpty Solution Transfer Container 1000Polymer Technology Corp. / cleared 1984-10-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)