Z-2127-2017Class II

PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use

Name: Z-2127-2017 PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use
Creator: Teleflex Medical
Published: 2017-04-21
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-04-21 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory on 2017-04-21. FDA classified it as Class II and gives the reason as "Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2127-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-21
Posted: 2017-05-22
Terminated: 2020-01-27
Recalling firm: Teleflex Medical
Product: PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Product code: GCD Connector, Catheter
Reason for recall: Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Consignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the Attn: Customer Service or email to [email protected]. A Recall Acknowledgment Form was enclosed to be completed and returned via fax even if they have no stock.
Quantity in commerce: 19,043 units in total
Distribution: Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.
Product codes and lots: Product Code: PE100, Lot numbers: 02F0801115, 02F0901859, 02G0802748, 02G0900814, 02H0900192, 02K0900567, 02L0900163, 02M0901006, 74A1601695, 74G1500137, 74G1502714 & 74M1400489.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2127-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2127-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22
Z-2128-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22
Z-2129-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22
Z-2130-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22

Product code GCD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)