The Recall Desk
HighFDA (Devices)·Z-2670-2014·Announced 2014-10-01

Centurion Medical Products Recalls Saline Flush Syringes Due to Open Seals

Centurion Medical Products is recalling 21,388 saline flush syringes used in convenience kits because open seals may compromise package integrity and sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential loss of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Centurion Medical Products Corporation is recalling 21,388 units of 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL (REF#306553). These syringes are used in Centurion Convenience Kits, and the recalled product is attached to the outside of the kits. The recall is due to unit packages that may exhibit open seals, which impacts package integrity and potentially product sterility.

The affected product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, VA, NC, IL, MA, OR, WA, IN, and SD. Specific lot numbers for the syringes include 4128353, 3046276, and 3024261, which were utilized in various Centurion convenience kits such as the Universal Central Line Insertion, Port Access Kit, and Universal Bundle Pack.

Healthcare facilities and consumers should check their inventory for these specific syringe lot numbers and kit codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit or replacement, as per standard recall procedures.

The recalled product

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.
Manufacturer
Centurion Medical Products Corporation
Category
Medical Device — Syringes
Hazard
Affected units
21,388

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 20 states:

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