Biopsy and laparoscopy packs recalled after being sterilized more than once
American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.
Plain-English summary
Medical convenience kits including the Basic Biopsy Tray and a range of laparoscopy packs are being recalled. Affected item numbers include AKRB26D (Robotic), AMGL09AA (General Laparoscopy), ANLC35AD (Lap Chole Pack), ANLP25AJ (Laparoscopy Pack), FYLA38E (LapCholAppy Pack), IHDA88AH (DaVinci Gyn Uro) and IHLC11AE (Lap General Pack).
The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.
The action covers 32,433 units in total across the firm's affected kits, distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.
Facilities should identify affected item, lot and bag serial numbers, quarantine them and follow the firm's instructions.
The recalled product
- Product
- Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical kit
- Hazard
- resterilization
- unvalidated-process
- sterility-assurance
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 (9)
- AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939
- AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364
- ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers 47862596 47862598
- FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260
- MHLP45AJ UDI-DI 191072236500 Lot 8527411 Bag serial number 68873222
- MHRB88AO UDI-DI 191072236531 Lot 8322811 Bag serial number 68596086
- RCLC51C UDI-DI 191072235930 Lot 8230311 Bag serial number N/A
- UDLC17AE UDI-DI 191072214072 Lot 8501711 Bag serial number 17744347
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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