Food, drugs, devices › B. Braun Medical, Inc.

Device recall: Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior

FDA enforcement event 78878 · Class II · initiated 21 Jun 2017 · status Terminated · terminated 3 Apr 2018

DeviceVoluntary: Firm initiated10 product recordsAllentown, PA

FDA enforcement event 78878 is a device recall by B. Braun Medical, Inc. of Allentown, PA, initiated 21 Jun 2017 and classified Class II, with 10 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 3 Apr 2018. Initiation: voluntary: firm initiated. B. Braun Medical, Inc. has 90 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

B. Braun Medical, Inc., Allentown, PA.

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 to the 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."

Distribution

"US Nationwide Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0567-2018	Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	8630 units	Class II	Terminated	21 Feb 2018
Z-0568-2018	Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	700	Class II	Terminated	21 Feb 2018
Z-0569-2018	Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	11,920 units	Class II	Terminated	21 Feb 2018
Z-0570-2018	Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	2480 units	Class II	Terminated	21 Feb 2018
Z-0571-2018	Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	6720 units	Class II	Terminated	21 Feb 2018
Z-0572-2018	PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	700 units	Class II	Terminated	21 Feb 2018
Z-0573-2018	Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	2660 units	Class II	Terminated	21 Feb 2018
Z-0574-2018	Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	120 units	Class II	Terminated	21 Feb 2018
Z-0575-2018	Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	460 units	Class II	Terminated	21 Feb 2018
Z-0576-2018	Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.	300 units	Class II	Terminated	21 Feb 2018

Context

93%of 2017 device events are Class II1,091 events that year

10product records in this eventfirm median: 1

90events on this register for the firm

Other enforcement events for B. Braun Medical, Inc.

Initiated	Product (first record)	Type	Class	Records
19 Aug 2026	0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc	Drug	Class I	1
12 Aug 2026	Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-35	Drug	Class I	1
4 Aug 2026	Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025	Device	Class II	1
6 May 2026	Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);	Device	Class I	3
28 Apr 2026	Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0	Drug	Class I	1
2 Apr 2026	Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801	Drug	Class II	4
19 Mar 2026	B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.	Device	Class I	6
2 Feb 2026	Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N	Device	Class II	3
29 Jan 2026	Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Vers	Device	Class II	8
29 Oct 2025	ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar	Device	Class II	116

All 90 events for B. Braun Medical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the 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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 3 Apr 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.