Abg Point Lok Needle Protection Device

• 3 recalls, same reason

  • Terminated Z-0860-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004 ·via K954015, on the same 510(k)
  • Terminated Z-0859-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004 ·via K954015, on the same 510(k)
  • Terminated Z-0858-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004 ·via K954015, on the same 510(k)

  Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K954015 ↗

FDA Product Code

CBT

Device Class

Class I

Regulation

21 CFR Part 868.1100

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Magnetic Drape - Instrument Holder

  Class II

  FDA 510(k) K780865 Active Cleared 21 Aug 1978

• Sponge Counter

  Class I

  FDA 510(k) K790538 Active Cleared 4 Apr 1979

• Electrosurgical Tip Cleaner & Holder

  Class II

  FDA 510(k) K803055 Active Cleared 12 Feb 1981

• Surgical Instrument Protector

  Class II

  FDA 510(k) K771123 Active Cleared 28 Oct 1977

• The Sharps Collection and Disposal System

  Class II

  FDA 510(k) K945197 Active Cleared 2 Dec 1994

• Easy-On

  Class I

  FDA 510(k) K932998 Active Cleared 18 Aug 1993

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