Z-0948-2019Class II

AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

Name: Z-0948-2019 AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
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 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL 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-0948-2019
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 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL 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: 5
Distribution: Nationwide distribution.
Product codes and lots: 74A1700874 74G1702797 74F1700146 74H1701106 74F1701964

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2019
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)