Z-0952-2019Class II

AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control...

Name: Z-0952-2019 AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control...
Creator: Arrow International Inc
Published: 2018-10-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-10-02 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump on 2018-10-02. FDA classified it as Class II and gives the reason as "Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak...". 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-0952-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-02
Posted: 2019-02-25
Terminated: 2021-11-12
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 2, 2018, the firm notified consignees via an Urgent Medical Device Recall letter. The letter informed customers of the product issue. Customers were instructed to take the following actions: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have any other questions, feel free to contact your local sales representative or Teleflex Customer Service at 1-866-396-2111.
Quantity in commerce: 26
Distribution: Nationwide distribution.
Product codes and lots: 74A1600493 74E1701689 74A1701278 74F1601947 74B1700147 74G1601342 74B1700922 74H1601292 74C1601403 74H1602005 74C1601458 74J1601528 74C1601839 74K1601040 74C1602928 74K1601957 74C1702397 74L1601996 74D1600766 74L1602670 74E1600739 74M1501120 74E1601599 74M1600311 74E1700481 74M1600671

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0952-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0941-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0942-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0943-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0944-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0945-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0946-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0947-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0948-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0949-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0950-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0951-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0952-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0953-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0954-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0955-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25
Z-0956-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-25

Product code MEB

K090300Class IIModification to AutofuserAce Medical Us, LLC / cleared 2009-04-30

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)