Centurion Medical Products Corporation 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
Brand
Centurion Medical Products Corporation
Lot Codes / Batch Numbers
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, Lot Numbers: 2013082850, 2013092650, Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180, Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350, 2013082950, 2013091250, Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880, Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950, Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780, Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150, Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380, Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980, Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880, 2013111180, Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750, Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480, Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080, Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280, Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780, Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180, Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880, Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080, Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080, Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880, 2013061780, 2013072980, 2013111180, Kit Code/Description: DT17300/NEONATAL CAP CHANGE KIT, Lot Numbers: 2013052880, 2013111880, Kit Code/Description: DT17410/ON/OFF KIT & DRESSING CHANGE TRAY, Lot Numbers: 2013050680, 2013061780, Kit Code/Description: DT17880C/DRIVELINE MGMT SYST - PROTOCOL 2, Lot Number: 2013040180, Kit Code/Description: ECVC150/MULTI-LUMEN CVC KIT W/ELS VANTEX CATHETE, Lot Number: 2013091950, Kit Code/Description: ECVC355/ CHARLES COLE CVC INSERTION BUNDLE, Lot Numbers: 2013082050, 2013091950, Kit Code/Description: ECVC510/CENTRAL LINE INSERTION TRAY, Lot Number: 2013081550, Kit Code/Description: ECVC585/CENTRAL LINE INSERTION TRAY BUNDLE, Lot Number: 2013082950, Kit Code/Description: ECVC705/7FR, 20CM, 3L ANTIMICROBIAL CVC BUNDLE, Lot Number: 2013091750, Kit Code/Description: ECVC740/MULTI-LUMEN CVC BUNDLE, Lot Number: 2013092650, Kit Code/Description: HT5525/V.A.D.KIT, Lot Number: 2013062480, Kit Code/Description: HT5545/SUB-PORT ACCESS TRAY: Lot Number: 2013052880, & Kit Code/Description: IV7610/ARTERIAL LINE INSERTION KIT, Lot Numbers: 2013052080.
Products Sold
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) Syringes Ref #306553, Lot Numbers 4128353, 3046276, 3024261 were utilized in the following Centurion convenience kits: Kit Code/Description: CVI3210/UNIVERSAL CENTRAL LINE INSERTION, Lot Numbers: 2013082850, 2013092650; Kit Code/Description: CVI3240/PORT ACCESS KIT, Lot Number: 2013111180; Kit Code/Description: CVI3425/CVC UNIVERSAL BUNDLE, Lot Numbers: 2013081350,2013082950, 2013091250; Kit Code/Description: CVI3525/UNIVERSAL BUNDLE PACK, Lot Number: 2013052880; Kit Code/Description: CVI3535/CENTRAL LINE INSERTION TRAY, Lot Numbers: 2013092450, 2013081950; Kit Code/Description: DT10560/INFUSION PORT ACCESS KIT, Lot Number: 2013061780; Kit Code/Description: DT10620/FISTULA KIT, Lot Number: 2013082150; Kit Code/Description: DT11270/VAD KIT, Lot Number: 2013051380; Kit Code/Description: DT11390/ONCOLOGY PORT ACCESS TRAY (MED GLOVES), Lot Numbers: 2013052080, 2013072980; Kit Code/Description: DT11395/ONCOLOGY PORT ACCESS (NO GLOVES), Lot Numbers: 2013052880, 2013111180; Kit Code/Description: DT12955/UNIVERSAL PROCEDURE PACK, Lot Number: 2013091750; Kit Code/Description: DT13610/PICC INSERTION KIT, Lot Numbers: 2013061780, 2013062480; Kit Code/Description: DT13775/PORT ACCESS/CENTRAL LINE TRAY, Lot Number: 2013052080; Kit Code/Description: DT14645/PORT ACCESS TRAY, Lot Number: 2013120280; Kit Code/Description: DT14680/CAP CHANGING KIT, Lot Numbers: 2013061080, 2013061780; Kit Code/Description: DT14835/CAP CHANGE KIT, Lot Number: 2013111180; Kit Code/Description: DT14860/PORT DRESSING CHANGE KIT WITH MED SHIELD, Lot Number: 2013102880; Kit Code/Description: DT15060/SINGLE PORT ACCESS TRAY W/SORBAVIEW, Lot Numbers: 2013050680, 2013040180, 2013061080; Kit Code/Description: DT15220/STERILE CAP CHANGE, Lot Numbers: 2013052880, 2013061080; Kit Code/Description: DT16040/PORT ACCESS TRAY, Lot Numbers:, 2013052880,2013061780, 2013072980, 2013111180; Kit Code/Description: DT17300/NEONATAL CAP CHANGE KIT, Lot Numbers: 2013052880, 2013111880; Kit Code/Description: DT17410/ON/OFF KIT & DRESSING CHANGE TRAY, Lot Numbers: 2013050680, 2013061780; Kit Code/Description: DT17880C/DRIVELINE MGMT SYST - PROTOCOL 2, Lot Number: 2013040180; Kit Code/Description: ECVC150/MULTI-LUMEN CVC KIT W/ELS VANTEX CATHETE, Lot Number: 2013091950; Kit Code/Description: ECVC355/ CHARLES COLE CVC INSERTION BUNDLE, Lot Numbers: 2013082050, 2013091950; Kit Code/Description: ECVC510/CENTRAL LINE INSERTION TRAY, Lot Number: 2013081550; Kit Code/Description: ECVC585/CENTRAL LINE INSERTION TRAY BUNDLE, Lot Number: 2013082950; Kit Code/Description: ECVC705/7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Lot Number: 2013091750; Kit Code/Description: ECVC740/MULTI-LUMEN CVC BUNDLE, Lot Number: 2013092650; Kit Code/Description: HT5525/V.A.D.KIT, Lot Number: 2013062480; Kit Code/Description: HT5545/SUB-PORT ACCESS TRAY: Lot Number: 2013052880; & Kit Code/Description: IV7610/ARTERIAL LINE INSERTION KIT, Lot Numbers: 2013052080.
Centurion Medical Products Corporation is recalling 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used due to Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IL, IN, IA, MD, MA, NE, NY, NC, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026