The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2370-2014·Announced 2014-09-10

Customed Recalls PERl GYN PACK Surgical Kits Due to Packaging Integrity Concerns

Customed, Inc. is recalling 43 lots of PERl GYN PACK surgical kits because packaging integrity may be compromised, potentially leading to loss of sterility.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"

Plain-English summary

Customed, Inc. has initiated a recall of 43 lots of PERl GYN PACK surgical kits, totaling 3,201 units. The recall involves multiple catalog numbers and specific lot codes ranging from 110051144 to 140513473. The affected products are EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.

The recall was issued because Customed determined there is a possibility that packaging integrity may be compromised on these lots. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients using the devices.

The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users of these medical devices should check their inventory against the listed lot codes and contact Customed, Inc. for further instructions on how to return or dispose of the affected units.

The recalled product

Product
PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X 20" UF (1) TOP DRAPE WITH ADHESIVE STD SMS (1) CATHETER NELATON ROB. 14FR. (2) GOWN IMPERVIOUS EXTRA REINFORCED XL (1) UNDERBUITOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) TABLE…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Kits
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 (1)

  • Product code 900-1061

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 233 recalled by Customed, 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 233 products in this recall →

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