The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0737-2017·Announced 2016-12-21

C.R. Bard Recalls Piston Syringes Due to Package Defect Risk

C.R. Bard is recalling specific lots of 60cc Piston Syringes because a package slit defect may compromise product sterility.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility due to a packaging defect. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity rating.

Plain-English summary

C.R. Bard, Inc. is recalling specific lots of BARD Piston Syringes, 60cc, Rx Only, Sterile. The recall is due to a package defect where products may have a slit on the package, which may affect the product's sterility.

The affected product is a single-use plastic syringe with a 60cc or 70cc capacity graduated barrel, a thumb ring plunger, and included catheter and Luer adapter tips. It is indicated for catheter irrigation, Cytoscope or Resectoscope irrigation, and Foley catheter balloon inflation. The recall includes product code 750375 and lot numbers NGZC4960, NGZD3108, NGZE1244, NGZE3556, and NGZF2584.

The affected syringes were distributed nationwide in the United States and internationally to Australia, New Zealand, Canada, Mexico, France, and Italy. Healthcare facilities and consumers should check their inventory for these specific lot numbers and discontinue use if found.

The recalled product

Product
BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Syringes
Hazard

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 (5)

  • Product Code: 750375
  • Lot Numbers: NGZC4960
  • NGZD3108
  • NGZE1244
  • NGZE3556 and NGZF2584.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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