Z-0568-2018Class II

Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin...

Name: Z-0568-2018 Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin...
Creator: B. Braun Medical, Inc.
Published: 2017-06-21
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2017-06-21 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle on 2017-06-21. FDA classified it as Class II and gives the reason as "B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release...". 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-0568-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-21
Posted: 2018-02-09
Terminated: 2018-04-03
Recalling firm: B Braun Medical Inc
Product: Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to [email protected] within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.
Quantity in commerce: 700
Distribution: US Nationwide Distribution.
Product codes and lots: 0061523813. 0061536453.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0567-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0568-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0569-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0570-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0571-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0572-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0573-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0574-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0575-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09
Z-0576-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code FMI

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